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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K260274
Device Name Airlock® Ankle Plating System
Applicant
Novastep SAS
2, Allée Jacques Frimot
Rennes,  FR 35000
Applicant Contact Manon Dupleichs
Correspondent
Novastep SAS
2, Allée Jacques Frimot
Rennes,  FR 35000
Correspondent Contact Manon Dupleichs
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/29/2026
Decision Date 03/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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