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B-One Ortho, Corp.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories4
Latest FDA decision2026-04-13
TypeNumberDevice NameCodeDateActions
510(k) K253357 b-ONE® Bipolar HeadKWY2026-04-13 View
510(k) K240528 b-ONE® Total Hip SystemLZO2024-11-15 View
510(k) K222431 b-ONER MOBIO Total Knee SystemJWH2022-10-06 View
510(k) K213673 b-ONE MOBIO Total Knee SystemJWH2022-01-21 View
510(k) K212912 OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula SystemMAI2021-11-04 View
510(k) K210483 MOBIO Total Knee SystemJWH2021-04-21 View
510(k) K202768 KOSMO Femoral StemLZO2021-04-01 View
510(k) K202429 Mobio Total Knee SystemJWH2020-10-23 View
510(k) K182705 Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System CupsLZO2019-02-14 View
510(k) K183025 MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar ComponentJWH2019-01-28 View
510(k) K180446 b-ONE Total Knee SystemJWH2018-10-12 View
510(k) K173380 b-ONE® Total Hip SystemLZO2018-08-30 View
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