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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K230724
Device Name arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
Applicant
Novastep
2, Allée Jacques Frimot
Rennes,  FR 35000
Applicant Contact Gilles Audic
Correspondent
Novastep
2, Allée Jacques Frimot
Rennes,  FR 35000
Correspondent Contact Manon Dupleichs
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/16/2023
Decision Date 12/04/2023
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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