K243912
- 510(k) number
- K243912
- Device name
- Newclip Patient-matched instrumentation non sterile PSI
- Applicant
- Newclip Technics FR
- Product code
- PBF — Orthopaedic Surgical Planning And Instrument Guides
- Decision date
- 2025-02-13
- Date received
- 2024-12-19
- 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: K243912.pdf
Official FDA record: K243912
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.