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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 K112663
Device Name ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL
Applicant
Enhatch Orthopaedics, LLC
1050 Wall St.
West Suite 340
Lyndhurst,  NJ  07071
Applicant Contact MICHAEL PHIPPS
Correspondent
Enhatch Orthopaedics, LLC
1050 Wall St.
West Suite 340
Lyndhurst,  NJ  07071
Correspondent Contact MICHAEL PHIPPS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/13/2011
Decision Date 03/12/2012
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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