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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 K180821
Device Name TruMatch Graft Cage - Long Bone
Synthes (USA) LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Christopher J. Medberry
Synthes (USA) LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Christopher J. Medberry
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
Date Received03/30/2018
Decision Date 12/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No