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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt, Nut, Non-Spinal, Metallic
510(k) Number K052483
Device Name SYNTHES (USA) SPHERICAL WASHERS
Applicant
Synthes (Usa)
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact LISA M BOYLE
Correspondent
Synthes (Usa)
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact LISA M BOYLE
Regulation Number888.3030
Classification Product Code
NDG  
Subsequent Product Code
HWC  
Date Received09/09/2005
Decision Date 11/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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