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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K943589
Device Name STRYKER TOTAL PERFORMANCE SYSTEM
Applicant
Stryker Corp.
4100 E Milham Ave.
Portage,  MI  49002
Applicant Contact TAMMY LOUNDS
Correspondent
Stryker Corp.
4100 E Milham Ave.
Portage,  MI  49002
Correspondent Contact TAMMY LOUNDS
Regulation Number878.4820
Classification Product Code
HWE  
Date Received07/22/1994
Decision Date 12/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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