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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 K240415
Device Name Newclip Patient-matched instrumentation non sterile PSI
Applicant
Newclip Technics
Pa De La Lande Saint Martin
45 Rue Des Garottieres
Haute Goulaine,  FR 44115
Applicant Contact Robert Poggie
Correspondent
Newclip Technics
Pa De La Lande Saint Martin
45 Rue Des Garottieres
Haute Goulaine,  FR 44115
Correspondent Contact Robert Poggie
Regulation Number888.3030
Classification Product Code
PBF  
Date Received02/12/2024
Decision Date 11/07/2024
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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