This page includes the latest FDA filings for B One Ortho Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3016093326 |
| FEI Number | 3016093326 |
| Name | B-ONE ORTHO, CORP. |
| Owner & Operator | b-ONE Ortho, Corp. |
| Contact Address | 3 Wing Drive Suite #259 Cedar Knolls NJ 07927 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 636 Shelby Street Floor 4 Bristol, TN 37620 US |
| Registration Number | 3015259876 |
| FEI Number | 3015259876 |
| Name | B-ONE ORTHO, CORP. |
| Owner & Operator | b-ONE Ortho, Corp. |
| Contact Address | 3 Wing Drive Suite #259 Cedar Knolls NJ 07927 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3 Wing Drive Suite #259 Cedar Knolls, NJ 07927 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03079 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03078 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03077 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03076 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03075 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03074 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03073 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03072 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03065 | 2025-02-20 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03080 | 2025-02-05 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03059 | 2025-02-05 |
| B-ONE ORTHO, CORP. | b-ONE Hip Specialty 8819P00001 | 2025-01-30 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105330 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105329 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105328 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105327 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105326 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105325 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105324 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105323 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105322 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105321 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105310 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105309 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105308 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105307 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105306 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105305 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105304 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105303 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105302 | 2024-10-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829105301 | 2024-10-16 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03057 | 2024-09-02 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829408009 | 2024-08-27 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829408013 | 2024-08-27 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829408012 | 2024-08-27 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829408000 | 2024-08-27 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829920001 | 2024-08-27 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829910001 | 2024-08-27 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829940001 | 2024-08-27 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8829950002 | 2024-08-27 |
| B-ONE ORTHO, CORP. | Slotted Pin Puller 8829003010 | 2024-03-15 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03036 | 2023-12-18 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03031 | 2023-12-18 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03028 | 2023-12-18 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313116 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313114 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313113 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313112 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313111 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313110 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313109 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313019 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313016 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313014 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313013 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313012 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313011 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313010 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821313009 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323719 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323716 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323714 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323713 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323712 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323711 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323710 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323709 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323519 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323516 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323514 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323513 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323512 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323511 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323510 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323509 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323319 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323316 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323314 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323313 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323312 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323311 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323310 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323309 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323119 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323116 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323114 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323113 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323112 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323111 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323110 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323109 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323019 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323016 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323014 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323013 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323012 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323011 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323010 | 2023-05-25 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821323009 | 2023-05-25 |
B-ONE ORTHO, Corp. | B-ONER MOBIO Total Knee System | 2022-10-06 |
B-ONE ORTHO, Corp. | B-ONE MOBIO Total Knee System | 2022-01-21 |
B-ONE ORTHO, Corp | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System | 2021-11-04 |
B-ONE ORTHO, Corp. | MOBIO Total Knee System | 2021-04-21 |
B-One Ortho Corp. | KOSMO Femoral Stem | 2021-04-01 |
B-One Ortho, Corp. | Mobio Total Knee System | 2020-10-23 |
B-ONE Ortho Corp. | Juveno Hip System Femoral Stem, B-ONE Primary Acetabular System Cups | 2019-02-14 |
B-One Ortho Corp. | MOBIO Total Knee System Posterior Stabilized (PS And PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | 2019-01-28 |
B-One Ortho Corp. | B-ONE Total Knee System | 2018-10-12 |
B-One Ortho Corp. | B-ONE® Total Hip System | 2018-08-30 |