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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 K212545
Device Name FlexitSystem Knee osteotomy system
Applicant
Neosteo
Malleve 2a, 1 Blvd. Jean Moulin
Nantes,  FR 44 100
Applicant Contact JD Webb
Correspondent
The OrthoMedix Group, Inc.
4314 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact JD Webb
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/12/2021
Decision Date 02/11/2022
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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