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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 K110125
Device Name 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
Applicant
Synthes USA
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact CHRISTOPHER HACK, ESQ.
Correspondent
Synthes USA
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact CHRISTOPHER HACK, ESQ.
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/18/2011
Decision Date 04/21/2011
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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