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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K946313
Device Name TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER
Applicant
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008
Applicant Contact DAN W MILLER
Correspondent
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008
Correspondent Contact DAN W MILLER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/28/1994
Decision Date 03/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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