Genesys Spine
Genesys Spine appears in FDA public data with 0 recalls, 31 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Oct 22, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 31
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252322 | SIros-X System | Oct 22, 2025 |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Feb 7, 2025 |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | Mar 29, 2024 |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Dec 13, 2023 |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | Mar 9, 2022 |
| K191489 | Genesys Spine 3DP Cervical Interbody System | Jan 8, 2020 |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | Dec 12, 2019 |
| K192678 | Genesys Spine Binary® Lumbar Plate System | Oct 24, 2019 |
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | Sep 26, 2019 |
| K192076 | Binary® Anterior Cervical Plate System | Aug 29, 2019 |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | Aug 29, 2018 |
| K173885 | Genesys Spine Binary Lumbar Plate System | Apr 3, 2018 |
| K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | Mar 28, 2018 |
| K172469 | TiLock Modular Spinal System | Nov 30, 2017 |
| K171838 | TiLock2 Spinal System | Jul 19, 2017 |
| K171656 | Genesys Spine Apache Interbody Fusion System | Jul 13, 2017 |
| K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | Nov 8, 2016 |
| K161914 | Genesys Spine TiLock Cortical Spinal System | Aug 9, 2016 |
| K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion System | Jul 28, 2016 |
| K161404 | Genesys Spine Apache® Lateral Lumbar Interbody Fusion System | Jul 21, 2016 |