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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopaedic Surgical Planning And Instrument Guides
510(k) Number K221615
Device Name Newclip Patient-matched instrumentation non sterile PSI
Applicant
Newclip Technics
P.A. De La Lande Saint Martin - 45 Rue Des Garottieres
Haute-Goulaine,  FR 44115
Applicant Contact Gaelle Gourbiere
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre Dame De Lile Perrot,  CA J7W3J6
Correspondent Contact Robert A. Poggie
Regulation Number888.3030
Classification Product Code
PBF  
Date Received06/03/2022
Decision Date 10/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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