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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 K212640
Device Name Stratum® Ankle Fusion Plating System
Applicant
Nextremity Solutions, Inc.
1195 Polk Dr.
Warsaw,  IN  46582
Applicant Contact Elise Fox
Correspondent
Nextremity Solutions, Inc.
1195 Polk Dr.
Warsaw,  IN  46582
Correspondent Contact Elise Fox
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   KCT   LXH  
Date Received08/20/2021
Decision Date 11/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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