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™ Total Knee System 8821411710 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821411609 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821411509 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821411408 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821411307 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821411207 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341025 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341022 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341019 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341016 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341013 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341011 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341010 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341009 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341825 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341822 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341819 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341816 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341813 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341811 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341810 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341809 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341725 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341722 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341719 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341716 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341713 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341711 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341710 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341709 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341525 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341522 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341519 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341516 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341513 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341511 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341510 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341509 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341325 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341322 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341319 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341316 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341313 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341311 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341310 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341309 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341125 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341122 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341119 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341116 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341113 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341111 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341110 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821341109 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331025 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331022 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331019 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331016 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331013 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331011 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331010 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331009 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331725 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331722 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331719 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331716 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331713 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331711 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331710 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331709 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331525 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331522 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331519 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331516 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331513 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331511 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331510 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331509 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331325 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331322 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331319 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331316 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331313 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331311 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331310 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331309 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331125 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331122 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331119 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331116 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331113 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331111 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331110 | 2026-03-16 |
| B-ONE ORTHO, CORP. | MOBIO™ Total Knee System 8821331109 | 2026-03-16 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P05006 | 2026-02-23 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P05005 | 2026-02-23 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P05004 | 2026-02-23 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P05003 | 2026-02-23 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P05002 | 2026-02-23 |
| B-ONE ORTHO, CORP. | Mobio™ Specialty 8829P03090 | 2026-02-23 |
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 |