K232097
- 510(k) number
- K232097
- Device name
- IdentiTi ALIF Interbody Systems
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-09-25
- Date received
- 2023-07-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K232097.pdf
Official FDA record: K232097
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.