Calibrate CCX Interbody System
FDA 510(k) clearance K232504 · decided 2023-10-13
Clearance details
- K-number
- K232504
- Device name
- Calibrate CCX Interbody System
- Applicant
- Alphatec Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-18
- Decision date
- 2023-10-13
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- MAX
- 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 |
|---|---|---|
| Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O recall (Z-1065-2025) | Alphatec Spine, Inc. | 2025-01-30 |