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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, trunnion-bearing
510(k) Number K811630
Device Name KINEMATIC ROTATING HINGE TOTAL KNEE PR.
Applicant
HOWMEDICA CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HOWMEDICA CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number888.3530
Classification Product Code
LGE  
Date Received06/09/1981
Decision Date 07/01/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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