Cleared Traditional

Newclip Patient-matched instrumentation non sterile PSI

K221615 · Newclip Technics · Orthopedic

Oct 2023

Decision

509d

Days

Class 2

Risk

About This 510(k) Submission

K221615 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 25, 2023, 509 days after receiving the submission on June 3, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K221615 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2022
Decision Date	October 25, 2023
Days to Decision	509 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.