K233075
- 510(k) number
- K233075
- Device name
- BioGend Interbody Fusion System 001 Cage
- Applicant
- Biogend Therapeutics Co., Ltd. TW
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-03-06
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233075.pdf
Official FDA record: K233075
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.