| Primary Device ID | 00819034026159 |
| NIH Device Record Key | cdc1f380-2097-4dcc-9ce9-1d1eb28241e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FuzeFix Large |
| Version Model Number | TN-FX-6040 |
| Catalog Number | TN-FX-6040 |
| Company DUNS | 080307067 |
| Company Name | FUSION ORTHOPEDICS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 00819034026159 [Primary] |
| GDZ | Handle, Scalpel |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
[00819034026159]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-26 |
| Device Publish Date | 2023-06-16 |
| 00819034028320 | Headless Screw HL 5.5mm x 45mm |
| 00819034028313 | Cannulated Screw HD 5.5mm x 45mm |
| 00819034027330 | FX Wire Sleeve 7.0mm |
| 00819034027323 | FX Drill Sleeve 7.0mm |
| 00819034027316 | FX Sleeve 5.5mm and 7.0mm |
| 00819034027309 | FX Drill Sleeve 5.5mm |
| 00819034027293 | FX Wire Sleeve 5.5mm |
| 00819034027286 | Parallel Wire Guide HD 5.5mm |
| 00819034027279 | Parallel Wire Guide HD 7.0mm |
| 00819034027262 | Parallel Wire Guide HL 7.0mm |
| 00819034026883 | Depth Gauge HL 5.5mm/7.0mm |
| 00819034026876 | Depth Gauge HD 5.5mm/7.0mm |
| 00819034026203 | Screw Holding Forceps Large |
| 00819034026180 | 7.0mm Guide 4.9mm and 2.8mm |
| 00819034026173 | 5.5mm Guide 3.6mm and 2.0mm |
| 00819034025824 | Screw Extractor Rod 7.0mm |
| 00819034025817 | Screw Extractor Rod 5.5mm |
| 00819034025749 | Driver Torx 7.0mm |
| 00819034025732 | Driver Torx 5.5mm |
| 00819034025725 | Proximal Reamer Cannulated 7.0mm |
| 00819034025718 | Proximal Reamer Cannulated 5.5mm |
| 00819034025107 | K-Wire Threaded 2.0mm |
| 00819034025022 | K-Wire Standard 2.0mm |
| 00819034025015 | Tap Cannulated 7.0mm |
| 00819034025008 | Tap Cannulated 5.5mm |
| 00819034024964 | Driver Torx Removal 7.0mm |
| 00819034024957 | Driver Torx Removal 5.5mm |
| 00819034024940 | K-Wire Threaded 2.8mm |
| 00819034024933 | K-Wire Threaded 1.6mm |
| 00819034024926 | K-Wire Standard 2.8mm |
| 00819034024919 | K-Wire Standard 1.6mm |
| 00819034024865 | Proximal Reamer Headless 7.0mm |
| 00819034024858 | Proximal Reamer Headless 5.5mm |
| 00819034024834 | Calibrated Drill Cannulated 4.9mm |
| 00819034024827 | Calibrated Drill Cannulated 3.6mm |
| 00819034029686 | FX Parallel Wire Guide HL 5.5mm |
| 00840124502253 | HD FT 5.5mm x 90mm |
| 00840124502239 | HD FT 5.5mm x 80mm |
| 00840124502222 | HD FT 5.5mm x 75mm |
| 00840124502215 | HD FT 5.5mm x 70mm |
| 00840124502208 | HD FT 5.5mm x 65mm |
| 00840124502192 | HD FT 5.5mm x 60mm |
| 00840124502185 | HD FT 5.5mm x 55mm |
| 00840124502178 | HD FT 5.5mm x 50mm |
| 00840124502161 | HD FT 5.5mm x 48mm |
| 00840124502154 | HD FT 5.5mm x 46mm |
| 00840124502147 | HD FT 5.5mm x 45mm |
| 00840124502130 | HD FT 5.5mm x 44mm |
| 00840124502123 | HD FT 5.5mm x 42mm |
| 00840124502116 | HD FT 5.5mm x 40mm |