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 IDK202429
510k NumberK202429
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 Received2020-08-25
Decision Date2020-10-23

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