| Primary Device ID | 00843575121219 |
| NIH Device Record Key | f858fd90-2748-4a32-8fac-4a8b92ddb13a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | b-ONE Hip Specialty |
| Version Model Number | 8819P00001 |
| Catalog Number | 8819P00001 |
| Company DUNS | 081315444 |
| Company Name | B-ONE ORTHO, CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843575121219 [Primary] |
| HTS | Knife, Orthopedic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
[00843575121219]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-30 |
| Device Publish Date | 2025-01-22 |
| 00843575124630 - Mobio™ Specialty | 2026-02-23 Femoral A/P Sizer and External Rotation Guide (PR) |
| 00843575128416 - Mobio™ Specialty | 2026-02-23 PR 4-IN-1 CUTTING BLOCK SIZE 2 |
| 00843575128423 - Mobio™ Specialty | 2026-02-23 PR 4-IN-1 CUTTING BLOCK SIZE 3 |
| 00843575128430 - Mobio™ Specialty | 2026-02-23 PR 4-IN-1 CUTTING BLOCK SIZE 4 |
| 00843575128447 - Mobio™ Specialty | 2026-02-23 PR 4-IN-1 CUTTING BLOCK SIZE 5 |
| 00843575128454 - Mobio™ Specialty | 2026-02-23 PR 4-IN-1 CUTTING BLOCK SIZE 6 |
| 00843575128461 - Mobio™ Specialty | 2026-02-23 PR 4-IN-1 CUTTING BLOCK SIZE 7 |
| 00843575128478 - Mobio™ Specialty | 2026-02-23 PR 4-IN-1 CUTTING BLOCK SIZE 8 |