| Primary Device ID | 00628184003862 |
| NIH Device Record Key | a98cf9a7-3c47-4983-bc13-0bf6ea70715b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | intellijoint HIP(R) |
| Version Model Number | 000-0386 |
| 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 | 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 |
| Phone | 15193423178 |
| info@intellijointsurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628184003862 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00628184003862]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-09 |
| Device Publish Date | 2019-08-09 |
| 00628184008003 - intellijoint HIP (R) | 2024-07-08 Intellijoint HIP Kit Lateral Platform |
| 00628184008010 - intellijoint HIP (R) | 2024-07-08 Intellijoint HIP Kit Ellipse Disc |
| 00628184008027 - intellijoint KNEE (R) | 2024-07-08 Intellijoint KNEE Kit |
| 00628184008034 - intellijoint HIP (R) | 2024-07-08 Intellijoint HIP Kit, Long Femur Screw - 10 Pack |
| 00628184008119 - intellijoint HIP (R) | 2024-07-08 Pelvic Screw (136 mm) Sterile |
| 00628184008126 - intellijoint HIP (R) | 2024-07-08 Femur Screw (18 mm) Sterile |
| 00628184008133 - intellijoint HIP (R) | 2024-07-08 Femur Screw (26 mm) Sterile |
| 00628184008140 - intellijoint HIP (R) | 2024-07-08 Femoral Disc, Ellipse Sterile |