| Primary Device ID | 00628184005743 |
| NIH Device Record Key | 1a757b71-407a-4705-bb60-39201eef9b57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intellijoint KNEE(R) |
| Version Model Number | 000-0574 |
| Company DUNS | 202958070 |
| Company Name | Intellijoint Surgical Inc |
| 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 |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com | |
| Phone | 519-342-3178 |
| regulatory@intellijointsurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628184005743 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
| 00628184519004 | Bone Screw |
| 00628184005743 | Fluted Bone Pins |