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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, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
510(k) Number K830726
Device Name MARK I & II TOTAL KNEE REPLACE. SYS
Applicant
Advanced Biosearch Assn.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Advanced Biosearch Assn.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3560
Classification Product Code
MBV  
Date Received03/08/1983
Decision Date 06/22/1983
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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