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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K211313
Device Name MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
Applicant
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Suchitra Basu
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Suchitra Basu
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
OSN  
Date Received04/30/2021
Decision Date 05/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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