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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, femorotibial, non-constrained, cemented, metal/polymer
510(k) Number K121974
Device Name CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
Original Applicant
CONFORMIS, INC.
11 north avenue
burlington,  MA  01803
Original Contact amita s shah
Regulation Number888.3520
Classification Product Code
HSX  
Date Received07/05/2012
Decision Date 09/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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