K242216
- 510(k) number
- K242216
- Device name
- GENTAFIX® (1, 3, 3MV)
- Applicant
- Teknimed Sas FR
- Product code
- MBB — Bone Cement, Antibiotic
- Decision date
- 2024-12-18
- Date received
- 2024-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242216.pdf
Official FDA record: K242216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.