MOBIO Total Knee System

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

B-ONE ORTHO, Corp.

The following data is part of a premarket notification filed by B-one Ortho, Corp. with the FDA for Mobio Total Knee System.

Pre-market Notification Details

Device IDK210483
510k NumberK210483
Device Name:MOBIO Total Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant b-ONE ORTHO, Corp. 3 Wing Drive Suite # 259 Cedar Knolls,  NJ  07927
ContactAllison Gecik
CorrespondentAllison Gecik
b-ONE ORTHO, Corp. 3 Wing Drive Suite # 259 Cedar Knolls,  NJ  07927
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-19
Decision Date2021-04-21

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