K232996
- 510(k) number
- K232996
- Device name
- Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
- Applicant
- Shanghai Iatrical-Ti Technologies CO , Ltd. CN
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-06
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K232996.pdf
Official FDA record: K232996
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.