| 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 |
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| 00628184005590 - intellijoint KNEE® | 2021-03-02 Probe Adaptor 1.3 - 1.4mm |
| 00628184005606 - intellijoint KNEE® | 2021-03-02 Probe Adaptor 1.5 - 1.6mm |
| 00628184005613 - intellijoint KNEE® | 2021-03-02 Probe Adaptor 1.7 - 1.8mm |
| 00628184002810 - intellijoint navigation system | 2020-07-15 Camera, USB, G2 |
| 00628184004012 - intellijoint HIP® | 2020-07-15 Angled Probe |
| 00628184003930 - intellijoint HIP® | 2020-06-17 Pelvic Platform, Mini |
| 00628184002704 - intellijoint HIP® | 2020-04-01 Arm, Camera Mount, Magnetic Base |