VIPER F2 FACET FIXATION SYSTEM
FDA 510(k) clearance K101762 · decided 2010-11-15
Clearance details
- K-number
- K101762
- Device name
- VIPER F2 FACET FIXATION SYSTEM
- Applicant
- Depuy Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-22
- Decision date
- 2010-11-15
- Days to decision
- 146 days
- Clearance type
- Special
- Product code
- MRW
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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| CORUS-LX Implant (K253190) | Providence Medical Technology, Inc. | 2025-11-20 |
| FFX Facet Fixation System (K252153) | Sc Medica | 2025-10-16 |
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| Arthrex Spine Compression FT Screw (K250920) | Arthrex, Inc. | 2025-05-22 |
| The Karma® Fixation System (K242527) | Spinal Elements, Inc. | 2025-05-21 |
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| Ion 3D (K243265) | SurGenTec, LLC | 2024-12-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IN MOTION LUMBAR ARTIFICIAL DISC (P040006/S005) | Depuy Spine, Inc. | 2011-02-08 |
| IN MOTION ARTIFICIAL DISC (P040006/S004) | Depuy Spine, Inc. | 2007-09-05 |
| CHARITE ARTIFICIAL DISC (P040006/S003) | Depuy Spine, Inc. | 2006-12-15 |
| CHARITE ARTIFICIAL DISC (P040006/S002) | Depuy Spine, Inc. | 2006-03-29 |
| CHARITE ARTIFICIAL DISC (P040006/S001) | Depuy Spine, Inc. | 2005-06-16 |
| CHARITE ARTIFICIAL DISC (P040006) | Depuy Spine, Inc. | 2004-10-26 |
| LUMBAR I/F CAGE SYSTEM (P960025/S010) | Depuy Spine, Inc. | 2004-03-17 |
| SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE (P960025/S011) | Depuy Spine, Inc. | 2004-03-05 |