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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 K094017
Device Name TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
Applicant
OMNI LIFE SCIENCE, INC.
175 PARAMOUNT DRIVE
RAYNHAM,  MA  02767
Applicant Contact Robert Zoletti
Correspondent
OMNI LIFE SCIENCE, INC.
175 PARAMOUNT DRIVE
RAYNHAM,  MA  02767
Correspondent Contact Robert Zoletti
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/29/2009
Decision Date 03/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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