510(k) · Cleared
ClearedNuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 11, 2023 as substantially equivalent to K223731 (Nuvasive, Inc., 2023) and 6 other predicates after a 27-day review. Its family tree reaches back 27 generations to 1984. 1 of the 435 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Jul 11, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 27 generations to K841189 (1984). 425 ancestors in all, the oldest K792352 (1979). 9 later devices descend from it, 3 citing it directly. 1 of the 435 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- 2 generations backK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- 1 generation backK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
- This deviceK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- Descendant · cites it directly · 3 of its ownK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
- Descendant · cites it directly · 2 of its ownK240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System…Orthofix Medical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK253876 HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261882 Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 7 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 6 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 4 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 3 generations backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- 2 generations backK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- 1 generation backK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
- This deviceK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 9 · See all- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine · 2025 · cites it directly3descendants
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc. · 2024 · cites it directly2descendants
- K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc. · 2025 · cites it directly1descendant
- K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026 · 2 generations on0descendants
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −4 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −3 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
| −2 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| −1 | K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023 | — |
| 0 (this device) | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| +1 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
| +1 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C… | Orthofix Medical, Inc. | 2024 | — |
| +1 | K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | 2025 | — |
| +2 | K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026 | — |
| +2 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 13 | 0 |
| 2002 | 13 | 0 |
| 2003 | 17 | 0 |
| 2004 | 30 | 0 |
| 2005 | 21 | 0 |
| 2006 | 12 | 0 |
| 2007 | 18 | 0 |
| 2008 | 49 | 1 |
| 2009 | 31 | 0 |
| 2010 | 23 | 0 |
| 2011 | 29 | 0 |
| 2012 | 12 | 0 |
| 2013 | 19 | 0 |
| 2014 | 26 | 0 |
| 2015 | 19 | 0 |
| 2016 | 9 | 0 |
| 2017 | 13 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K223731 | NuVasive Modulus-C Interbody SystemSummary page 6…NuVasive CoRoent Small Interlock System, NuVasive CoRoent Small Interlock II System, NuVasive Small Ti-C System, and NuVasive Cohere Cervical Interbody System cleared in K223731, K163491, K142050, K192582, K170961, K162138, and K173030 respectively. D. Device Description NuVasive CoRoent Small Interbody… | 2023 |
| * | K163491 | NuVasive CoRoent Small Interbody SystemSummary page 6…CoRoent Small Interlock System, NuVasive CoRoent Small Interlock II System, NuVasive Small Ti-C System, and NuVasive Cohere Cervical Interbody System cleared in K223731, K163491, K142050, K192582, K170961, K162138, and K173030 respectively. D. Device Description NuVasive CoRoent Small Interbody System:… | 2017 |
| * | K142050 | Nuvasive Coroent Small Contoured Interbody SystemSummary page 6…mall Interlock System, NuVasive CoRoent Small Interlock II System, NuVasive Small Ti-C System, and NuVasive Cohere Cervical Interbody System cleared in K223731, K163491, K142050, K192582, K170961, K162138, and K173030 respectively. D. Device Description NuVasive CoRoent Small Interbody System: The NuVa… | 2014 |
| * | K192582 | NuVasive CoRoent Small Interlock SystemSummary page 6…rlock System, NuVasive CoRoent Small Interlock II System, NuVasive Small Ti-C System, and NuVasive Cohere Cervical Interbody System cleared in K223731, K163491, K142050, K192582, K170961, K162138, and K173030 respectively. D. Device Description NuVasive CoRoent Small Interbody System: The NuVasive CoRo… | 2019 |
| * | K170961 | NuVasive CoRoent Small Interlock II SystemSummary page 6…tem, NuVasive CoRoent Small Interlock II System, NuVasive Small Ti-C System, and NuVasive Cohere Cervical Interbody System cleared in K223731, K163491, K142050, K192582, K170961, K162138, and K173030 respectively. D. Device Description NuVasive CoRoent Small Interbody System: The NuVasive CoRoent Small… | 2017 |
| * | K162138 | NuVasive CoRoent Small Ti-C SystemSummary page 6…sive CoRoent Small Interlock II System, NuVasive Small Ti-C System, and NuVasive Cohere Cervical Interbody System cleared in K223731, K163491, K142050, K192582, K170961, K162138, and K173030 respectively. D. Device Description NuVasive CoRoent Small Interbody System: The NuVasive CoRoent Small Interbod… | 2016 |
| * | K173030 | Vertera Spine Cohere Cervical Interbody Fusion DeviceSummary page 6…Small Interlock II System, NuVasive Small Ti-C System, and NuVasive Cohere Cervical Interbody System cleared in K223731, K163491, K142050, K192582, K170961, K162138, and K173030 respectively. D. Device Description NuVasive CoRoent Small Interbody System: The NuVasive CoRoent Small Interbody System is d… | 2017 |
| † | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System… | 2021 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 43 of the 425 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241375 (Alphatec Spine, 2025) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K223731.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 -…
Read the full statement (831 words)
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
The CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to or a bone void filler as cleared by the FDA for use in intervertebral body fusion facilitate fusion. The cervical devices are to be used in patient who have had at least six weeks of non-operative treatment.
The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
The Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231735: NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231735
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026