B-One Ortho, Corp.
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories4
Latest Approval2026-04-13
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253357 | b-ONE® Bipolar Head | KWY | 2026-04-13 | View |
| 510(k) | K240528 | b-ONE® Total Hip System | LZO | 2024-11-15 | View |
| 510(k) | K222431 | b-ONER MOBIO Total Knee System | JWH | 2022-10-06 | View |
| 510(k) | K213673 | b-ONE MOBIO Total Knee System | JWH | 2022-01-21 | View |
| 510(k) | K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System | MAI | 2021-11-04 | View |
| 510(k) | K210483 | MOBIO Total Knee System | JWH | 2021-04-21 | View |
| 510(k) | K202768 | KOSMO Femoral Stem | LZO | 2021-04-01 | View |
| 510(k) | K202429 | Mobio Total Knee System | JWH | 2020-10-23 | View |
| 510(k) | K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups | LZO | 2019-02-14 | View |
| 510(k) | K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | JWH | 2019-01-28 | View |
| 510(k) | K180446 | b-ONE Total Knee System | JWH | 2018-10-12 | View |
| 510(k) | K173380 | b-ONE® Total Hip System | LZO | 2018-08-30 | View |
No matching devices.