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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K223468
Device Name Nexis® compressive screws
Applicant
Novastep
2, Allée Jacques Frimot
Rennes,  FR 350000
Applicant Contact Gilles Audic
Correspondent
Novastep
2, Allée Jacques Frimot
Rennes,  FR 350000
Correspondent Contact Gilles Audic
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/17/2022
Decision Date 08/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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