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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K810060
Device Name P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH
Applicant
Howmedica Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Howmedica Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3530
Classification Product Code
HRY  
Date Received01/13/1981
Decision Date 04/07/1981
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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