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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 K133449
Device Name KASM KNEE ARTICULATING SPACER MOLDS
Applicant
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Applicant Contact MIKE ENSIGN
Correspondent
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Correspondent Contact MIKE ENSIGN
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBB  
Date Received11/12/2013
Decision Date 02/18/2014
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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