K232792
- 510(k) number
- K232792
- Device name
- icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
- Applicant
- Icotec AG CH
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-04-05
- Date received
- 2023-09-11
- 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: K232792.pdf
Official FDA record: K232792
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.