intellijoint navigation system
GUDID 00628184002810
Camera, USB, G2
Intellijoint Surgical Inc
Orthopaedic stereotactic surgery system| Primary Device ID | 00628184002810 |
| NIH Device Record Key | 1b71a573-c809-45e6-9798-757f0861a632 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | intellijoint navigation system |
| Version Model Number | 000-0281 |
| 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 | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com | |
| Phone | 1-519-342-3178 |
| info@intellijointsurgical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628184002810 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191507
FDA Product Code
| OLO | Orthopedic Stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-15 |
| Device Publish Date | 2020-07-07 |
Devices Manufactured by Intellijoint Surgical Inc
| 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 |
Trademark Results [intellijoint navigation system]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTELLIJOINT NAVIGATION SYSTEM 88793897 not registered Live/Pending |
Intellijoint Surgical Inc. 2020-02-12 |
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