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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K111667
Device Name SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact CHRISTOPHER HACK
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact CHRISTOPHER HACK
Regulation Number888.3030
Classification Product Code
JDS  
Date Received06/14/2011
Decision Date 12/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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