K221615
- 510(k) number
- K221615
- Device name
- Newclip Patient-matched instrumentation non sterile PSI
- Applicant
- Newclip Technics FR
- Product code
- PBF — Orthopaedic Surgical Planning And Instrument Guides
- Decision date
- 2023-10-25
- Date received
- 2022-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K221615.pdf
Official FDA record: K221615
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.