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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K110592
Device Name 3.7MM/5.0MM DYNAMIC LOCKING SCREW
Applicant
SYNTHES USA
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Applicant Contact CHRISTOPHER HACK, ESQ
Correspondent
SYNTHES USA
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Correspondent Contact CHRISTOPHER HACK, ESQ
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/02/2011
Decision Date 07/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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