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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 K905810
Device Name NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION
Applicant
Joint Medical Products Corp.
860 Canal St.
Stamford,  CT  06902
Applicant Contact DEBRA L BING
Correspondent
Joint Medical Products Corp.
860 Canal St.
Stamford,  CT  06902
Correspondent Contact DEBRA L BING
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/26/1990
Decision Date 06/12/1991
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
Recalls CDRH Recalls
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