Navigated Spine Instruments
FDA 510(k) clearance K203205 · decided 2021-03-23
Clearance details
- K-number
- K203205
- Device name
- Navigated Spine Instruments
- Applicant
- Stryker Spine
- Decision
- Substantially Equivalent
- Date received
- 2020-10-30
- Decision date
- 2021-03-23
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Leesburg, VA, US
- Third-party review
- No
- Expedited review
- No
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| OTS Hip (K261852) | Ortoma AB | 2026-07-01 |
| VERTICALE® Navigation Instruments (K253921) | Silony Medical GmbH | 2026-06-26 |
| VELYS™ Robotic-Assisted Solution (K260480) | Depuy Ireland UC | 2026-06-25 |
| Dynamis Robotic Surgical System (K260369) | LEM Surgical AG | 2026-06-20 |
| CORUS™ Navigation System-GN (K261665) | Providence Medical Technology, Inc. | 2026-06-18 |
| SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (K260571) | Life Spine, Inc. | 2026-06-02 |
| Navigated LLIF Impactable Tracker (K261060) | Tyber Medical, LLC | 2026-05-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RAY TFC AND RAY TFC UNITE (P950019/S014) | Stryker Spine | 2004-03-25 |
| RAY TFC UNITE (P950019/S016) | Stryker Spine | 2003-10-10 |
| RAY THREADED FUSION CAGE (TFC) (P950019/S015) | Stryker Spine | 2003-09-04 |
| RAY TFC UNITE PRODUCT LINE (P950019/S013) | Stryker Spine | 2003-07-15 |
| RAY TFC DEVICE/RAY TFC UNITE DEVICE (P950019/S012) | Stryker Spine | 2002-04-02 |
| RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION (P950019/S011) | Stryker Spine | 2000-03-30 |
| RAY TFC DEVICE AND RAY TFC UNITE DEVICE (P950019/S009) | Stryker Spine | 2000-03-02 |
| RAY THREADED FUSION CAGE(TFC) (P950019/S010) | Stryker Spine | 1999-12-01 |