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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, elbow, hemi-, radial, polymer
510(k) Number K112030
Device Name SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
Applicant
SYNTHES USA, LLC
1301 Goshen Parkway
west chester,  PA  19380
Applicant Contact angela f lassandro
Correspondent
SYNTHES USA, LLC
1301 Goshen Parkway
west chester,  PA  19380
Correspondent Contact angela f lassandro
Regulation Number888.3170
Classification Product Code
KWI  
Date Received07/15/2011
Decision Date 06/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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