GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k) clearance K111132 · decided 2011-12-09
Clearance details
- K-number
- K111132
- Device name
- GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- Genesys Spine
- Decision
- Substantially Equivalent
- Date received
- 2011-04-22
- Decision date
- 2011-12-09
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| ANTERIS Thoracolumbar Plate System (K260015) | SpineCraft | 2026-03-04 |
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| Aster (K254182) | Osteonic Co., Ltd. | 2026-02-26 |
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| aprevo® cervical plating system (K252611) | Carlsmed, Inc. | 2025-12-22 |
| Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (K251965) | Alphatec Spine, Inc. | 2025-08-28 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Pla recall (Z-0921-2013) | Genesys Orthopedic Systems, LLC | 2013-03-08 |