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B-One Ortho, Corp.

12 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
b-ONE® Bipolar Head (K253357)B-One Ortho, Corp.2026-04-13
b-ONE® Total Hip System (K240528)B-One Ortho, Corp.2024-11-15
b-ONER MOBIO Total Knee System (K222431)B-One Ortho, Corp.2022-10-06
b-ONE MOBIO Total Knee System (K213673)B-One Ortho, Corp.2022-01-21
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System (K212912)B-One Ortho, Corp.2021-11-04
MOBIO Total Knee System (K210483)B-One Ortho, Corp.2021-04-21
KOSMO Femoral Stem (K202768)B-One Ortho, Corp.2021-04-01
Mobio Total Knee System (K202429)B-One Ortho, Corp.2020-10-23
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups (K182705)B-One Ortho, Corp.2019-02-14
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component (K183025)B-One Ortho, Corp.2019-01-28
b-ONE Total Knee System (K180446)B-One Ortho, Corp.2018-10-12
b-ONE® Total Hip System (K173380)B-One Ortho, Corp.2018-08-30

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Every clearance here is in the API, with alerts when new ones post.