K242147
- 510(k) number
- K242147
- Device name
- Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-20
- Date received
- 2024-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K242147.pdf
Official FDA record: K242147
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.