Balanced Knee Revision System - Offset Junction Box

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Ortho Development Corporation

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Balanced Knee Revision System - Offset Junction Box.

Pre-market Notification Details

Device IDK180743
510k NumberK180743
Device Name:Balanced Knee Revision System - Offset Junction Box
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Ortho Development Corporation 12187 So. Business Park Drive Draper,  UT  84020
ContactDan Petersen
CorrespondentDan Petersen
Ortho Development Corporation 12187 So. Business Park Drive Draper,  UT  84020
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-22
Decision Date2018-06-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00822409037841 K180743 000
00822409037834 K180743 000
00822409037810 K180743 000
00822409037803 K180743 000

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