| Primary Device ID | 00850026574333 |
| NIH Device Record Key | aa1d1818-5f56-4961-bacc-fd15400ee450 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fusion Robotics Surgical Guidance System |
| Version Model Number | 3005 |
| Company DUNS | 117229400 |
| Company Name | Fusion Robotics, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00850026574333 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-12 |
| Device Publish Date | 2021-08-04 |
| 00850026574364 | Spine System Software |
| 00850026574357 | Camera Yoke |
| 00850026574340 | Fusion Robotics Surgical Guidance System |
| 00850026574333 | Camera Assembly |
| 00850026574258 | 8mm Hex Driver, Reference Arm |
| 00850026574241 | Reference Arm |
| 00850026574234 | Driver |
| 00850026574227 | 6.5mm Tap |
| 00850026574210 | 5.5mm Tap |
| 00850026574203 | 4.5mm Tap |
| 00850026574197 | Slap Hammer |
| 00850026574180 | Instrument Tracker |
| 00850026574173 | Awl Tap Cap |
| 00850026574166 | Awl |
| 00850026574159 | 8mm Guide Sleeve |
| 00850026574142 | Guide Tube with Tracker |
| 00850026574135 | Registration Array |