510(k) Report

510(k) · Cleared

Cleared

Oracle Lumbar Intervertebral Body Fusion Cage System

K121567510(k) TraditionalCleared Sep 26, 2012120-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Accel Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Sep 26, 2012 as substantially equivalent to K110783 (L&K BIOMED Co., Ltd., 2011) and 16 other predicates after a 120-day review. Its family tree reaches back 14 generations to 1984. 5 later devices descend from it.

Decided
Sep 26, 2012
Review
120 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
17

Its longest line of descent runs back 14 generations to K841189 (1984). 75 ancestors in all. 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2010: 4 other ancestors2009: 5 other ancestors2008: 5 other ancestors2007: 5 other ancestors2005: 5 other ancestors2006: 1 other ancestor2004: 9 other ancestors2003: 7 other ancestors2002: 6 other ancestors1999: 2 other ancestors2001: 7 other ancestors1996: 2 other ancestors2000: 1 other ancestor2020: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K090353 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 2009×3: 3 generations cleared close together, K113528 (2011), K120063 (2012), K121096 (2012) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 15 other ancestors3 generations back: 8 other ancestors4 generations back: 11 other ancestors5 generations back: 6 other ancestors6 generations back: 3 other ancestors7 generations back: 2 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K121096 · Venus Lumbar Intervertebral Body Fusion Cage System · L&K BIOMED Co., Ltd. · 2012K120063 · Venus Lumbar Intervertebral Body Fusion Cage System · L&K BIOMED Co., Ltd. · 2012K113528 · Clydesdale (R) Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011K090353 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 2009K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations between
  3. 3 generations backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  4. 2 generations backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
  5. 1 generation backK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
  6. This deviceK121567 Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine · 2012
  7. Descendant · cites it directly · 3 of its ownK192863 MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020
  8. Descendant · 2 generations on · 1 of its ownK213641 MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022
  9. Descendant · 3 generations on · 0 of its ownK231715 MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024
  10. Descendant · 2 generations on · 0 of its ownK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
  11. Descendant · cites it directly · 0 of its ownK212389 Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC · 2021
Show all 14 generations
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 5 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 4 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
  12. 3 generations backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  13. 2 generations backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
  14. 1 generation backK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
  15. This deviceK121567 Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine · 2012

Most influential descendants

Showing 5 of 5 · See all
  • K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020 · cites it directly3descendants
  • K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022 · 2 generations on1descendant
  • K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024 · 3 generations on0descendants
  • K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023 · 2 generations on0descendants
  • K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−13K990148Stackable Cage SystemDepuy Motech Acromed1999—
−12K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−11K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−10K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−9K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−8K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−7K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−6K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−5K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−4K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009—
−3K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011—
−2K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.2012—
−1K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.2012—
0 (this device)K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine2012—
+1K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation2020—
+2K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation2022—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation2024—
+2K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation2023—
+1K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200170
200260
200370
200490
200550
200610
200750
200850
200950
201040
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
202210
202310
202410
FIG. 1 — Lineage of K121567, 1984–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in MAX? 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 MAX device

  1. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (17)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage
Summary page 2
…on Cage System is substantially equivalent to the following predicates: L&K BIOMEI): VENUS Lumbar Intervertebral Body Fusion Cage System (K 110783. K 120063. K 121096) .. S Medical: Any Plus PEEK Cage (K100516) .. STRYKER SPINE :AVS PEEK Spacer System (K08366 1,K090…
L&K BIOMED Co., Ltd.2011—
*K120063Venus Lumbar Intervertebral Body Fusion Cage System
Summary page 2
…ge System is substantially equivalent to the following predicates: L&K BIOMEI): VENUS Lumbar Intervertebral Body Fusion Cage System (K 110783. K 120063. K 121096) .. S Medical: Any Plus PEEK Cage (K100516) .. STRYKER SPINE :AVS PEEK Spacer System (K08366 1,K090816,K09370…
L&K BIOMED Co., Ltd.2012—
*K121096Venus Lumbar Intervertebral Body Fusion Cage System
Cleared while this submission was under review
Summary page 2
…is substantially equivalent to the following predicates: L&K BIOMEI): VENUS Lumbar Intervertebral Body Fusion Cage System (K 110783. K 120063. K 121096) .. S Medical: Any Plus PEEK Cage (K100516) .. STRYKER SPINE :AVS PEEK Spacer System (K08366 1,K090816,K093704) ..…
L&K BIOMED Co., Ltd.2012—
*K100516Anyplus Peek Cages
Summary page 2
…icates: L&K BIOMEI): VENUS Lumbar Intervertebral Body Fusion Cage System (K 110783. K 120063. K 121096) .. S Medical: Any Plus PEEK Cage (K100516) .. STRYKER SPINE :AVS PEEK Spacer System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (…
GS Medical Co., Ltd.2010—
*K083661Avs TL Peek Spacers
Summary page 2
…Body Fusion Cage System (K 110783. K 120063. K 121096) .. S Medical: Any Plus PEEK Cage (K100516) .. STRYKER SPINE :AVS PEEK Spacer System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (K092 162) .. Nuvasive: NuVasiveCoRoent System (K0434…
Stryker Corp.2009—
*K090816Stryker Spine Avs PL Peek Spacers
Summary page 2
…on Cage System (K 110783. K 120063. K 121096) .. S Medical: Any Plus PEEK Cage (K100516) .. STRYKER SPINE :AVS PEEK Spacer System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (K092 162) .. Nuvasive: NuVasiveCoRoent System (K043405,K0522…
Stryker Corp.2009—
*K093704Avs PL Peek Spacers
Summary page 2
…System (K 110783. K 120063. K 121096) .. S Medical: Any Plus PEEK Cage (K100516) .. STRYKER SPINE :AVS PEEK Spacer System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (K092 162) .. Nuvasive: NuVasiveCoRoent System (K043405,K0522 10 K07…
Stryker Corp.2009—
*K0921624CIS Peek, Plif and Tlif Cage System
Summary page 2
…. S Medical: Any Plus PEEK Cage (K100516) .. STRYKER SPINE :AVS PEEK Spacer System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (K092 162) .. Nuvasive: NuVasiveCoRoent System (K043405,K0522 10 K07 1795, KO081611) .. Spine Art : JULIET OL, DYNAMIK Interverte…
Solco Biomedical Co., Ltd.2010—
*K043405Nuvasive Coroent System
Summary page 2
…RYKER SPINE :AVS PEEK Spacer System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (K092 162) .. Nuvasive: NuVasiveCoRoent System (K043405,K0522 10 K07 1795, KO081611) .. Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888,…
Nuvasive, Inc.20051
*K052210Nuvasive Coroent Extensure System
Summary page 2
…INE :AVS PEEK Spacer System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (K092 162) .. Nuvasive: NuVasiveCoRoent System (K043405,K0522 10 K07 1795, KO081611) .. Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720)…
Nuvasive, Inc.2005—
*K071795Nuvasive Coroent System
Summary page 2
…PEEK Spacer System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (K092 162) .. Nuvasive: NuVasiveCoRoent System (K043405,K0522 10 K07 1795, KO081611) .. Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720) ..…
Nuvasive, Inc.2007—
*K081611Nuvasive Coroent System
Summary page 2
…System (K08366 1,K090816,K093704) .. Solco Biomedical : 4CIS PEEK PLIF Cage System (K092 162) .. Nuvasive: NuVasiveCoRoent System (K043405,K0522 10 K07 1795, KO081611) .. Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720) .. Medtronic…
Nuvasive, Inc.2008—
*K081888Dynamik Intervertebral Body Fusion Device
Summary page 2
….. Nuvasive: NuVasiveCoRoent System (K043405,K0522 10 K07 1795, KO081611) .. Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720) .. Medtronic Sofamorflanek: CLYDESDALE Spinal System (K100175,K112405,KI 13528)…
Spineart2009—
*K101720Juliet OL
Summary page 2
…vasive: NuVasiveCoRoent System (K043405,K0522 10 K07 1795, KO081611) .. Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720) .. Medtronic Sofamorflanek: CLYDESDALE Spinal System (K100175,K112405,KI 13528) 8. Con…
Spineart2010—
*K100175Clydesdale Spinal System
Summary page 2
…YNAMIK Intervertebral body fusion device (K081888, K101720) .. Medtronic Sofamorflanek: CLYDESDALE Spinal System (K100175,K112405,KI 13528) 8. Conclusion The Cezanne Lumbar Interbody Fusion Cage System is substantially equivalent to the devic…
Medtronic Sofamor Danek2010—
*K112405Clydesdales Spinal System
Summary page 2
…ntervertebral body fusion device (K081888, K101720) .. Medtronic Sofamorflanek: CLYDESDALE Spinal System (K100175,K112405,KI 13528) 8. Conclusion The Cezanne Lumbar Interbody Fusion Cage System is substantially equivalent to the device r…
Medtronic Sofamor Danek USA, Inc.2011—
*K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011—

Also cleared against K110783: 6 other devices →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203
K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 28 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
  • 7 of the 75 ancestors have a recall of any class.
  • Of its descendants, K192863 (Ctl Medical Corporation, 2020) has gone furthest, with 3 descendants of its own.
  • 6 other devices also cite its predicate K110783.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

Cezann& Lumbar Interbody Fusion Cage System is indicated for intervertebral body fuision procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-SI ODD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DOD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).This device is…

Read the full statement (106 words)

Cezann& Lumbar Interbody Fusion Cage System is indicated for intervertebral body fuision procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-SI ODD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DOD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Cezanne Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Indications for use as stated in the FDA summary.

Also cleared against K110783

6 other devices cite the same predicate.

  • K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2022
  • K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018
  • K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
  • K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
  • K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012

More from Accel Spine

10 FDA decisions under this applicant name. See the company

  • K140219Picasso II Mis Spinal SystemAccel Spine · 2014
  • K131981Cezanne II Interbody Fusion SystemAccel Spine · 20134 recalls
  • K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine · 2013
  • K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 20132 recalls
  • K121568Dali Spinal Fixation SystemAccel Spine · 2012

Recent decisions in MAX

The MAX category page

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  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K121567 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121567: Oracle Lumbar Intervertebral Body Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121567

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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