K232251
- 510(k) number
- K232251
- Device name
- APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
- Applicant
- Medartis AG CH
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2023-11-03
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K232251.pdf
Official FDA record: K232251
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.