K242364
- 510(k) number
- K242364
- Device name
- IdentiTi II Interbody System
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-10-04
- Date received
- 2024-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242364.pdf
Official FDA record: K242364
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.