Company · US
Genesys Spine
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2025. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 8 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 6 |
| NKB | Thoracolumbosacral Pedicle Screw System | 6 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 6 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| OUR | Sacroiliac Joint Fixation | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2025 | K252322 | SIros-X System Genesys Spine | OUR |
| Feb 7, 2025 | K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System Genesys Spine | OVE |
| Mar 29, 2024 | K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation Genesys Spine | OLO |
| Dec 13, 2023 | K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System Genesys Spine | OVE |
| Mar 9, 2022 | K220096 | Genesys Spine 3DP Lumbar Interbody System Genesys Spine | MAX |
| Jan 8, 2020 | K191489 | Genesys Spine 3DP Cervical Interbody System Genesys Spine | OVE |
| Dec 12, 2019 | K182987 | Genesys Spine 3DP Lumbar Interbody System Genesys Spine | MAX |
| Oct 24, 2019 | K192678 | Genesys Spine Binary® Lumbar Plate System Genesys Spine | KWQ |
| Sep 26, 2019 | K191748 | Genesys Spine Sacroiliac Joint Fusion System Genesys Spine | OUR |
| Aug 29, 2019 | K192076 | Binary® Anterior Cervical Plate System Genesys Spine | KWQ |
| Aug 29, 2018 | K181295 | Genesys Spine AIS-C Cervical Stand-Alone System Genesys Spine | OVE |
| Apr 3, 2018 | K173885 | Genesys Spine Binary Lumbar Plate System Genesys Spine | KWQ |
| Mar 28, 2018 | K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System Genesys Spine | OVE |
| Nov 30, 2017 | K172469 | TiLock Modular Spinal System Genesys Spine | NKB |
| Jul 19, 2017 | K171838 | TiLock2 Spinal System Genesys Spine | NKB |
| Jul 13, 2017 | K171656 | Genesys Spine Apache Interbody Fusion System Genesys Spine | MAX |
| Nov 8, 2016 | K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System Genesys Spine | MAX |
| Aug 9, 2016 | K161914 | Genesys Spine TiLock Cortical Spinal System Genesys Spine | NKB |
| Jul 28, 2016 | K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion System Genesys Spine | OVE |
| Jul 21, 2016 | K161404 | Genesys Spine Apache® Lateral Lumbar Interbody Fusion System Genesys Spine | MAX |
| Apr 26, 2016 | K153123 | Genesys Spine Apache Interbody Fusion System Genesys Spine | MAX |
| Oct 28, 2015 | K152039 | Genesys Spine TiLock2 Spinal System Genesys Spine | NKB |
| Sep 3, 2015 | K150812 | Genesys Spine Apache Cervical Interbody Fusion System Genesys Spine | ODP |
| Oct 8, 2014 | K133245 | GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM Genesys Spine | KWQ |
| Sep 3, 2014 | K133911 | GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM Genesys Spine | KWQ |
| Dec 13, 2013 | K130913 | GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM Genesys Spine | MAX |
| Dec 11, 2013 | K130317 | GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM Genesys Spine | ODP |
| Dec 9, 2011 | K111132 | GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM Genesys Spine | KWQ |
| Jul 21, 2011 | K103671 | GENESYS SPINE TILOCK SYSTEM Genesys Spine | NKB |
| Dec 10, 2010 | K103034 | GENESYS SPINE INTERBODY FUSION SYSTEM Genesys Spine | MAX |
| Jul 1, 2010 | K100757 | TILOCK PEDICLE SCREW SYSTEM Genesys Spine | NKB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||