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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 K180213
Device Name Titanium TomoFix Medial High Tibia Plate Anatomical
Applicant
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Stephan Jepards
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Stephan Jepards
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/25/2018
Decision Date 10/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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