| Primary Device ID | 00817701026846 |
| NIH Device Record Key | 0ab84626-65d1-4760-83d5-2b48b155b3a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InCore TMT |
| Version Model Number | IC-TMT-0129 |
| Company DUNS | 060783407 |
| Company Name | NEXTREMITY SOLUTIONS, 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817701026846 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
[00817701026846]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-18 |
| Device Publish Date | 2020-05-08 |
| 00817701027027 | InCore TMT 2.7mm x 52mm Titanium Screw |
| 00817701027010 | InCore TMT 2.7mm x 50mm Titanium Screw |
| 00817701026716 | InCore TMT 2.7mm x 46mm Titanium Screw |
| 00817701026709 | InCore TMT 2.7mm x 44mm Titanium Screw |
| 00817701026693 | InCore TMT 2.7mm x 42mm Titanium Screw |
| 00817701026686 | InCore TMT 2.7mm x 40mm Titanium Screw |
| 00817701026679 | InCore TMT 2.7mm x 38mm Titanium Screw |
| 00817701026662 | InCore TMT 2.7mm x 36mm Titanium Screw |
| 00817701026655 | InCore TMT 2.7mm x 34mm Titanium Screw |
| 00817701026648 | InCore TMT 2.7mm x 32mm Titanium Screw |
| 00817701026631 | InCore TMT 2.7mm x 30mm Titanium Screw |
| 00817701026624 | InCore TMT 2.7mm x 28mm Titanium Screw |
| 00817701026617 | InCore TMT 2.7mm x 26mm Titanium Screw |
| 00817701026600 | InCore TMT 2.7mm x 24mm Titanium Screw |
| 00817701026594 | InCore TMT 2.7mm x 22mm Titanium Screw |
| 00817701026587 | InCore TMT 2.7mm x 20mm Titanium Screw |
| 00817701026570 | InCore TMT 2.7mm x 18mm Titanium Screw |
| 00817701026563 | InCore TMT 2.7mm x 16mm Titanium Screw |
| 00817701026556 | InCore TMT 4.9mm x 18mm Left Titanium Post |
| 00817701026549 | InCore TMT 4.9mm x 18mm Right Titanium Post |
| 00817701026990 | InCore TMT 4.9mm Post Drill Sterile |
| 00817701026983 | InCore TMT 2.8mm Drill Bit Sterile |
| 00817701026976 | InCore TMT T8 Driver Sterile |
| 00817701026969 | InCore TMT Replacement Compression Screw |
| 00817701026952 | InCore TMT Replacement Compression Frame |
| 00817701026945 | InCore TMT Instrument Case Lid |
| 00817701026938 | InCore TMT Instrument Case |
| 00817701026921 | InCore TMT Torque Limiting Handle Reusable |
| 00817701026914 | InCore TMT Depth Probe Reusable |
| 00817701026907 | InCore TMT Removal Fastener Reusable |
| 00817701026891 | InCore TMT Removal Drill Guide Reusable |
| 00817701026884 | InCore TMT 2.8mm Drill Bit Reusable |
| 00817701026877 | InCore TMT T8 Driver Reusable |
| 00817701026860 | InCore TMT 4.9mm Post Drill Reusable |
| 00817701026853 | InCore TMT Post Fastener Reusable |
| 00817701026846 | InCore TMT Implant Bushing 70mm Reusable |
| 00817701026839 | InCore TMT Implant Bushing 55mm Reusable |
| 00817701026822 | InCore TMT Implant Bushing 40mm Reusable |
| 00817701026815 | InCore TMT Drill Bushing 70mm Reusable |
| 00817701026808 | InCore TMT Drill Bushing 55mm Reusable |
| 00817701026792 | InCore TMT Drill Bushing 40mm Reusable |
| 00817701026785 | InCore TMT Targeting Guide Assembly Right Reusable |
| 00817701026778 | InCore TMT Targeting Guide Assembly Left Reusable |
| 00817701026761 | InCore TMT Post Guide Reusable |
| 00817701026730 | InCore TMT 4.9mm Post Plug Screw |