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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