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FDA 510(k) Applications Submitted by b-ONE Ortho Corp.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180446
02/20/2018
b-ONE Total Knee System
b-One Ortho Corp.
K202768
09/21/2020
KOSMO Femoral Stem
b-One Ortho Corp.
K182705
09/27/2018
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
b-ONE Ortho Corp.
K183025
11/01/2018
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
b-One Ortho Corp.
K173380
10/30/2017
b-ONE« Total Hip System
b-One Ortho Corp.
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