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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K903877
Device Name MTS FEMORAL HIP SYSTEM
Applicant
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Applicant Contact WILLARD D LARSON
Correspondent
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Correspondent Contact WILLARD D LARSON
Regulation Number888.3360
Classification Product Code
KWL  
Date Received08/22/1990
Decision Date 01/18/1991
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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