| Primary Device ID | 03760225711019 |
| NIH Device Record Key | fe294227-1d2d-4460-a108-6a97da4913ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OS2 |
| Version Model Number | T01 00031 |
| Catalog Number | T01 00031 |
| Company DUNS | 263616749 |
| Company Name | IN2BONES |
| 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 | 03760225711019 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
[03760225711019]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2024-12-13 |
| 03701337618896 - QUANTUM® | 2025-12-17 QUANTUM® Rack Generic |
| 03701337618919 - QUANTUM® | 2025-12-17 QUANTUM® Rack Right |
| 03701337621995 - QUANTUM® | 2025-12-17 QUANTUM® Rack Left |
| 03701337612085 - QUANTUM | 2025-01-06 QUANTUM Temporary Fixed Insert Left Size 1 |
| 03701337600532 - QUANTUM | 2024-12-23 QUANTUM Talar Trial With Keel Right Size 1 |
| 03701337600549 - QUANTUM | 2024-12-23 QUANTUM Talar Trial With Keel Right Size 2 |
| 03701337600556 - QUANTUM | 2024-12-23 QUANTUM Talar Trial With Keel Right Size 3 |
| 03701337600563 - QUANTUM | 2024-12-23 QUANTUM Talar Trial With Keel Right Size 4 |