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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 K935080
Device Name INSALL-BURSTEIN II
Applicant
Hospital For Special Surgery
535 E. 70 St.
New York,  NY  10021
Applicant Contact BRUCE H ROBIE
Correspondent
Hospital For Special Surgery
535 E. 70 St.
New York,  NY  10021
Correspondent Contact BRUCE H ROBIE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/25/1993
Decision Date 05/22/1995
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
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