510(k) K243461
- Device
- Calibrate Interbody Systems
- Applicant
- Alphatec Spine, Inc.
- 510(k) number
- K243461
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-04
- Date received
- 2024-11-08
- Review panel
- Unknown
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Andrew Zhang
- Address
- 1950 Camino Vida Roble Carlsbad CA US 92008 92008