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. | Kosmo Femoral Hip System 8819040021 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040020 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040019 | 2025-04-15 |
| B-ONE ORTHO, CORP. | b-ONE Hip Instrumentation 8819910011 | 2025-04-15 |
| B-ONE ORTHO, CORP. | b-ONE Hip Instrumentation 8819910002 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819910103 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819910102 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810310023 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810310020 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810310017 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810310015 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810310013 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810310011 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810310009 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422280 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422270 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422260 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422255 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422250 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422245 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422240 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422235 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422230 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422225 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810422220 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402280 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402270 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402260 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402255 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402250 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402245 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402240 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402235 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402230 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402225 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402220 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8810402215 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040016 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040015 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040014 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040013 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040012 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040011 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040010 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040009 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040008 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040007 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040006 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040005 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040004 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040003 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040002 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819040001 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819000026 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819000025 | 2025-04-15 |
| B-ONE ORTHO, CORP. | Kosmo Femoral Hip System 8819000024 | 2025-04-15 |
| 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 8829P03031 | 2023-12-18 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03028 | 2023-12-18 |
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 |