FACET SCREW SYSTEM
FDA 510(k) clearance K101284 · decided 2010-07-15
Clearance details
- K-number
- K101284
- Device name
- FACET SCREW SYSTEM
- Applicant
- Nuvasive, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-07
- Decision date
- 2010-07-15
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- MRW
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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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 |
|---|---|---|
| Simplify® Cervical Artificial Disc (P200022/S016) | Nuvasive, Inc. | 2025-06-05 |
| Simplify® Cervical Artificial Disc (P200022/S017) | Nuvasive, Inc. | 2025-05-29 |
| Simplify Disc (P200022/S012) | Nuvasive, Inc. | 2025-02-18 |
| Simplify Cervical Artificial Disc (P200022/S015) | Nuvasive, Inc. | 2025-02-13 |
| Simplify Cervical Artificial Disc (P200022/S014) | Nuvasive, Inc. | 2024-12-18 |
| Simplify® Cervical Artificial Disc (P200022/S013) | Nuvasive, Inc. | 2024-04-17 |
| Simplify Disc (P200022/S011) | Nuvasive, Inc. | 2023-06-09 |
| Simplify Cervical Artificial Disc (P200022/S010) | Nuvasive, Inc. | 2023-03-15 |