| Primary Device ID | 00628184008010 |
| NIH Device Record Key | d14cf304-1536-462c-91c5-e3afbd6b667d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | intellijoint HIP (R) |
| Version Model Number | 000-0801 |
| Company DUNS | 202958070 |
| Company Name | Intellijoint Surgical Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00628184008010 [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 | 2024-07-08 |
| Device Publish Date | 2024-06-28 |
| 00628184008140 | Femoral Disc, Ellipse Sterile |
| 00628184008133 | Femur Screw (26 mm) Sterile |
| 00628184008126 | Femur Screw (18 mm) Sterile |
| 00628184008119 | Pelvic Screw (136 mm) Sterile |
| 00628184008034 | Intellijoint HIP Kit, Long Femur Screw - 10 Pack |
| 00628184008010 | Intellijoint HIP Kit Ellipse Disc |
| 00628184008003 | Intellijoint HIP Kit Lateral Platform |