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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reamer
510(k) Number K111437
Device Name SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact ANGELA F LASSANDRO
Correspondent
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact ANGELA F LASSANDRO
Regulation Number888.4540
Classification Product Code
HTO  
Subsequent Product Code
HRX  
Date Received05/24/2011
Decision Date 08/10/2011
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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