| Primary Device ID | 00840124525450 |
| NIH Device Record Key | ed198791-3b52-4746-953d-4d9d07273d8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Depth Gauge |
| Version Model Number | TN-DG-8000 |
| Catalog Number | TN-DG-8000 |
| Company DUNS | 080307067 |
| Company Name | FUSION ORTHOPEDICS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Donation Id Number | true |
| 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 | 00840124525450 [Primary] |
| HTJ | Gauge, Depth |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
[00840124525450]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-16 |
| Device Publish Date | 2026-03-06 |
| 00840124525474 - PolyLock Midfoot | 2026-03-18 Tapered Threaded Locking Screw 2.7mm x 48mm |
| 00840124525481 - PolyLock Midfoot | 2026-03-18 Compression Screw 2.7mm x 48mm |
| 00840124525450 - Depth Gauge | 2026-03-16General 1.0mm |
| 00840124525450 - Depth Gauge | 2026-03-16 General 1.0mm |
| 00840124525375 - FuzeFix Max FT | 2026-02-25 Fully Threaded Compression Screw FT 2.5mm x 32mm (Sterile) |
| 00840124525382 - FuzeFix Max FT | 2026-02-25 Fully Threaded Compression Screw FT 2.5mm x 34mm (Sterile) |
| 00840124525399 - FuzeFix Max FT | 2026-02-25 Fully Threaded Compression Screw FT 2.5mm x 36mm (Sterile) |
| 00840124525405 - FuzeFix Max FT | 2026-02-25 Fully Threaded Compression Screw FT 2.5mm x 38mm (Sterile) |
| 00840124525412 - FuzeFix Max FT | 2026-02-25 Fully Threaded Compression Screw FT 2.5mm x 42mm (Sterile) |