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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 K042899
FOIA Releasable 510(k) K042899
Device Name SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact SHERI L MUSGNUNG
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.4540
Classification Product Code
HTO  
Subsequent Product Code
NBH  
Date Received10/20/2004
Decision Date 03/16/2005
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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