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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K863668
Device Name OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
Applicant
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact DENNIS H CRANE
Correspondent
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact DENNIS H CRANE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/18/1986
Decision Date 12/19/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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