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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 K123457
Device Name BALANCED KNEE SYSTEM HIGH FLEX PS
Applicant
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Applicant Contact TOM HAUETER
Correspondent
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Correspondent Contact TOM HAUETER
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/08/2012
Decision Date 03/22/2013
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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