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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
510(k) Number K120479
Device Name MTF FASCIA
Applicant
Musculoskeletal Transplant Foundation
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact RANDY PREBULA
Correspondent
Musculoskeletal Transplant Foundation
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact RANDY PREBULA
Regulation Number878.3300
Classification Product Code
OWY  
Subsequent Product Code
OWW  
Date Received02/16/2012
Decision Date 11/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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