| Primary Device ID | 00819034021543 |
| NIH Device Record Key | 5bfceab4-8ffd-4030-8ae9-4ec41d24de1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FuzeFix Mini |
| Version Model Number | CD-FX-0511 |
| Company DUNS | 080307067 |
| Company Name | FUSION ORTHOPEDICS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | 00819034021543 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819034021543]
Moist Heat or Steam Sterilization
[00819034021543]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2019-04-19 |
| 00819034023202 | Screw Holding Forceps small |
| 00819034023172 | Depth Gauge HL |
| 00819034023165 | Depth Gauge HD |
| 00819034022236 | K-Wire Threaded 0.9 mm |
| 00819034021628 | Screw Extractor Rod 3.0mm and 4.0mm |
| 00819034021604 | Removal Driver Torx 4.0mm |
| 00819034021598 | Removal Driver Torx 3.0mm |
| 00819034021581 | Driver Torx 4.0mm |
| 00819034021574 | Driver Torx 3.0mm |
| 00819034021567 | Driver Torx 2.5mm |
| 00819034021550 | Driver Torx 2.0mm |
| 00819034021543 | K-Wire Threaded 1.1mm |
| 00819034021536 | K-Wire Standard 0.9mm |
| 00819034021529 | K-Wire Standard 1.1 mm |
| 00819034021512 | Proximal Reamer Headless 4.0mm |
| 00819034021505 | Proximal Reamer Headless 3.0mm |
| 00819034021499 | Proximal Reamer Headless 2.5mm |
| 00819034021482 | Proximal Reamer Headless 2.0mm |
| 00819034021475 | Proximal Reamer Cannulated 4.0 mm |
| 00819034021468 | Proximal Reamer Cannulated 3.0mm |
| 00819034021451 | Proximal Reamer Cannulated 2.5mm |
| 00819034021444 | Proximal Reamer Cannulated 2.0 mm |
| 00819034021437 | Calibrated Drill Cannulated 2.6 mm |
| 00819034021420 | Calibrated Drill Cannulated 2.2mm |
| 00819034021413 | Calibrated Drill Cannulated 1.9mm |
| 00819034021406 | Calibrated Drill Cannulated 1.7mm |
| 00819034029846 | Headless Screw HL 2.0mm x 37mm |
| 00819034029839 | Headless Screw HL 2.0mm x 32mm |
| 00840124506909 | Smooth Washer 4.0mm |
| 00840124506893 | Spiked Washer 3.0mnm |
| 00840124507166 | Cannulated Screw HD 4.0mm x 55mm |
| 00840124506886 | Cannulated Screw HD 4.00mm x 60mm |
| 00840124506879 | Cannulated Screw HD 4.0mm x 58mm |
| 00840124506862 | Cannulated Screw HD 4.0mm x 56mm |
| 00840124506855 | Cannulated Screw HD 4.0mm x 54mm |
| 00840124506848 | Cannulated Screw HD 4.0mm x 52mm |
| 00840124506831 | HL 4.0mm x 60mm |
| 00840124506824 | HL 4.0mm x 58mm |
| 00840124506817 | HL 4.0mm x 56mm |
| 00840124506701 | Tissue Protector Handle |
| 00840124506633 | Tissue Protector 4.0mm |
| 00840124506626 | Tissue Protector 3.0mm |
| 00840124506619 | Tissue Protector 2.5mm |
| 00840124506602 | Tissue Protector 2.0mm |
| 00840124501812 | Driver Handle Non-Ratcheting |
| 00840124501805 | Driver Handle Ratcheting |
| 00819034029297 | K-Wire Double Trocar 0.9mm |
| 00819034029280 | K-Wire Double Trocar 1.1mm |
| 00840124507173 | HL 4.0mm x 55mm |
| 00840124506800 | HL 4.0mm x 54mm |