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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 K161303
Device Name dynaMX™ Compression Plate
Applicant
MX ORTHOPEDICS, CORP.
1050 WALTHAM STREET
Suite 510
LEXINGTON,  MA  02421
Applicant Contact Howard L. Schrayer
Correspondent
MX ORTHOPEDICS, CORP.
1050 WALTHAM STREET
Suite 510
LEXINGTON,  MA  02421
Correspondent Contact Howard L. Schrayer
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/10/2016
Decision Date 01/26/2017
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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