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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Cement Removal Extraction
510(k) Number K961101
Device Name STRYKER CEMENT REMOVAL SYSTEM
Applicant
Stryker Corp.
2725 Fairfield Rd.
Kalamazoo,  MI  49002
Correspondent
Stryker Corp.
2725 Fairfield Rd.
Kalamazoo,  MI  49002
Regulation Number888.4580
Classification Product Code
LZV  
Date Received03/19/1996
Decision Date 07/15/1996
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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