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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 K243912
Device Name Newclip Patient-matched instrumentation non sterile PSI
Applicant
Newclip Technics
Pa De La Lande Saint Martin
45 Rue Des Garottières
Haute Goulaine,  FR 44115
Applicant Contact Gaëlle Gourbiere
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre Dame De Lile Perrot,  CA J7W3J6
Correspondent Contact Robert Poggie
Regulation Number888.3030
Classification Product Code
PBF  
Date Received12/19/2024
Decision Date 02/13/2025
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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