Cleared Traditional

Newclip Patient-matched instrumentation non sterile PSI

K250767 · Newclip Technics · Orthopedic
Oct 2025
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K250767 is an FDA 510(k) clearance for the Newclip Patient-matched instrumentation non sterile PSI, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by Newclip Technics (Haute Goulaine, FR). The FDA issued a Cleared decision on October 1, 2025, 202 days after receiving the submission on March 13, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250767 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2025
Decision Date October 01, 2025
Days to Decision 202 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code PBF — Orthopaedic Surgical Planning And Instrument Guides
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030
Definition As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.