510(k) · Cleared
ClearedCarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 25, 2024 as substantially equivalent to K210716 (CarboFix Orthopedics, Ltd., 2021) and 9 other predicates after a 29-day review. Its family tree reaches back 23 generations to 2004. 2 of the 642 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Apr 25, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 23 generations to K040583 (2004). 639 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly. 2 of the 642 devices in this family, counting this one, have a Class I recall.
- Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations between
- 3 generations backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- 2 generations backK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
- 1 generation backK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
- This deviceK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK233793 CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
Show all 23 generations
- Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 22 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 20 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 19 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 18 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 16 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 15 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 14 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 13 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 12 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 11 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 10 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 9 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 8 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 7 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 6 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 5 generations backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- 4 generations backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- 3 generations backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- 2 generations backK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
- 1 generation backK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
- This deviceK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −22 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −20 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −19 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −18 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −16 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −15 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −14 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −13 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −12 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −11 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −10 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −9 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −8 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −7 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −6 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −5 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| −4 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| −3 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| −2 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments… | CarboFix Orthopedics, Ltd. | 2023 | — |
| −1 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2024 | — |
| 0 (this device) | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated… | CarboFix Orthopedics, Ltd. | 2024 | — |
| +1 | K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +1 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 3 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 17 | 0 |
| 1996 | 12 | 0 |
| 1997 | 14 | 0 |
| 1998 | 23 | 0 |
| 1999 | 24 | 0 |
| 2000 | 32 | 0 |
| 2001 | 45 | 0 |
| 2002 | 31 | 0 |
| 2003 | 33 | 0 |
| 2004 | 47 | 0 |
| 2005 | 41 | 0 |
| 2006 | 33 | 0 |
| 2007 | 29 | 1 |
| 2008 | 33 | 0 |
| 2009 | 26 | 0 |
| 2010 | 28 | 1 |
| 2011 | 29 | 0 |
| 2012 | 18 | 0 |
| 2013 | 17 | 0 |
| 2014 | 15 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
2 devices in this family have 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsSummary page 6…opedic 3. PML; Bone Cement, Posterior Screw Augmentation PREDICATE DEVICES Primary Predicate Device: CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716, K231280, K233944). Additional Predicate Devices: 1. CarboClear® X Navigated Instruments (CarboFix Orthopedics Ltd.; K210… | 2021 |
| * | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…Summary page 6…. PML; Bone Cement, Posterior Screw Augmentation PREDICATE DEVICES Primary Predicate Device: CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716, K231280, K233944). Additional Predicate Devices: 1. CarboClear® X Navigated Instruments (CarboFix Orthopedics Ltd.; K210716,… | 2023 |
| * | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsSummary page 6…Bone Cement, Posterior Screw Augmentation PREDICATE DEVICES Primary Predicate Device: CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716, K231280, K233944). Additional Predicate Devices: 1. CarboClear® X Navigated Instruments (CarboFix Orthopedics Ltd.; K210716, K231… | 2024 |
| * | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Summary page 6…w System, High V+® Bone Cement (CarboFix Orthopedics Ltd.; K231280) 3. VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (Icotec ag; K190545, K193423) 4. VADER® Pedicle System, G21 Cement (Icotec ag; K200596, K222789) 5. CD HORIZON® Spinal System (Medtronic… | 2019 |
| * | K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Summary page 6…High V+® Bone Cement (CarboFix Orthopedics Ltd.; K231280) 3. VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (Icotec ag; K190545, K193423) 4. VADER® Pedicle System, G21 Cement (Icotec ag; K200596, K222789) 5. CD HORIZON® Spinal System (Medtronic Sofamor D… | 2020 |
| * | K200596 | G21 Cement, VADER® Pedicle SystemSummary page 6…80) 3. VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (Icotec ag; K190545, K193423) 4. VADER® Pedicle System, G21 Cement (Icotec ag; K200596, K222789) 5. CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) 6. CD HORIZON™ Fenestrated Screw S… | 2020 |
| * | K222789 | VADER® Pedicle System, G21 CementSummary page 6…3. VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (Icotec ag; K190545, K193423) 4. VADER® Pedicle System, G21 Cement (Icotec ag; K200596, K222789) 5. CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) 6. CD HORIZON™ Fenestrated Screw Set (Medtr… | 2023 |
| * | K082236 | CD Horizon Spinal SystemSummary page 6…otec ag; K190545, K193423) 4. VADER® Pedicle System, G21 Cement (Icotec ag; K200596, K222789) 5. CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) 6. CD HORIZON™ Fenestrated Screw Set (Medtronic Sofamor Danek; K170347) 7. Medtronic Navigated Manual Reusa… | 2008 |
| * | K170347 | CD HORIZON™ Fenestrated Screw SetSummary page 6…ag; K200596, K222789) 5. CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) 6. CD HORIZON™ Fenestrated Screw Set (Medtronic Sofamor Danek; K170347) 7. Medtronic Navigated Manual Reusable Instruments (Medtronic Sofamor Danek; K153442 and more) INDICATIONS FOR… | 2017 |
| * | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Summary page 6…6. CD HORIZON™ Fenestrated Screw Set (Medtronic Sofamor Danek; K170347) 7. Medtronic Navigated Manual Reusable Instruments (Medtronic Sofamor Danek; K153442 and more) INDICATIONS FOR USE CarboClear® Hybrid Pedicle Screw System CarboClear® Hybrid Pedicle Screw System (Oncology) The Ca… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 6 months on median.
- 75 of the 639 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K233793 (CarboFix Orthopedics, Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K210716.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
CarboClear® Hybrid Pedicle Screw System (Oncological) The CarboClear® Hybrid Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CarboClear® Hybrid Pedicle Screw System (DDD) The CarboClear® Hybrid Pedicle Screw…
Read the full statement (974 words)
CarboClear® Hybrid Pedicle Screw System (Oncological)
The CarboClear® Hybrid Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
CarboClear® Hybrid Pedicle Screw System (DDD)
The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade | spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
CarboClear® Hybrid Navigated Instruments
CarboClear® Hybrid Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Hybrid Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Hybrid Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
CarboClear® Hybrid Fenestrated Pedicle Screw System
When used in conjunction with High V+® Bone Cement, the CarboClear® Hybrid Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® Hybrid Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
When used without cement, the CarboClear® Hybrid Fenestrated Pedicle Screws are intended:
(a) to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
(b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade | spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
High V+® Bone Cement
When used in conjunction with the CarboClear® Hybrid Fenestrated Pedicle Screw System, High V+® Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
CarboClear® X Fenestrated Pedicle Screw System
When used in conjunction with High V+® Bone Cement, the CarboClear® X Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
When used without cement, the CarboClear® X Fenestrated Pedicle Screw System is intended:
(a) to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
(b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade | spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® X Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
High V+® Bone Cement
When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
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/K240846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240846: CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240846
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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