K250767
- 510(k) number
- K250767
- Device name
- Newclip Patient-matched instrumentation non sterile PSI
- Applicant
- Newclip Technics FR
- Product code
- PBF — Orthopaedic Surgical Planning And Instrument Guides
- Decision date
- 2025-10-01
- Date received
- 2025-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K250767.pdf
Official FDA record: K250767
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.