K240415
- 510(k) number
- K240415
- Device name
- Newclip Patient-matched instrumentation non sterile PSI
- Applicant
- Newclip Technics FR
- Product code
- PBF — Orthopaedic Surgical Planning And Instrument Guides
- Decision date
- 2024-11-07
- Date received
- 2024-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K240415.pdf
Official FDA record: K240415
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.