| Primary Device ID | 00850069061791 |
| NIH Device Record Key | b1050c6d-1e6d-4d1b-adb1-460c47a58532 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Metalogix Revolution |
| Version Model Number | 656150 |
| Catalog Number | 656150 |
| 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 | 00850069061791 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
[00850069061791]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-01 |
| Device Publish Date | 2025-07-24 |
| 00840124521315 | 6mm Pin Cap |
| 00840124521308 | 5mm Pin Cap |
| 00840124521292 | 4mm Pin Cap |
| 00840124521285 | 3mm Pin Cap |
| 00850069061012 | Standard Bolt |
| 00850069061807 | 5x60x165mm Self-Drill Half-Pin |
| 00850069061791 | 5x60x165mm Self-Drill Half-Pin |
| 00840124521209 | 4x30x165mm Short Self-Drill Half-Pin |
| 00840124521193 | 4x20x165mm Short Self-Drill Half-Pin |
| 00840124521186 | 3x30x165mm Short Self-Drill Half-Pin |
| 00840124521179 | 3x20x165mm Short Self-Drill Half-Pin |
| 00840124521131 | 5x40x165mm Self-Drill Half-Pin |
| 00840124521124 | 5x30x165mm Self-Drill Half-Pin |