IdentiTi ALIF Interbody Systems
FDA 510(k) clearance K232097 · decided 2023-09-25
Clearance details
- K-number
- K232097
- Device name
- IdentiTi ALIF Interbody Systems
- Applicant
- Alphatec Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-13
- Decision date
- 2023-09-25
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiT recall (Z-1182-2024) | Alphatec Spine, Inc. | 2024-02-23 |