K241375
- 510(k) number
- K241375
- Device name
- IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
- Applicant
- Alphatec Spine CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-02-03
- Date received
- 2024-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K241375.pdf
Official FDA record: K241375
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.