Calibrate Interbody Systems
FDA 510(k) clearance K243461 · decided 2025-03-04
Clearance details
- K-number
- K243461
- Device name
- Calibrate Interbody Systems
- Applicant
- Alphatec Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-08
- Decision date
- 2025-03-04
- Days to decision
- 116 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.