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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, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K040487
Device Name TRABECULAR METAL KNEE SYSTEM AUGMENTS
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Applicant Contact MARCI HALEVI
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Correspondent Contact MARCI HALEVI
Regulation Number888.3565
Classification Product Code
MBH  
Date Received02/25/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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