| Primary Device ID | 00817701026129 |
| NIH Device Record Key | e6a1df90-18a4-4fec-aadc-c2f3d9fe9ade |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InCore MPJ |
| Version Model Number | IC-MPJ-0116 |
| Company DUNS | 192756786 |
| Company Name | Medartis Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 00817701026129 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
[00817701026129]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2020-11-17 |
| 00817701026754 | InCore MPJ 2.7mm x 52mm Titanium Screw |
| 00817701026747 | InCore MPJ 2.7mm x 50mm Titanium Screw |
| 00817701026495 | InCore MPJ Implant Bushing 70mm Reusable |
| 00817701026488 | InCore MPJ Implant Bushing 55mm Reusable |
| 00817701026471 | InCore MPJ Implant Bushing 40mm Reusable |
| 00817701026242 | InCore MPJ 4.9mm Post Drill Sterile |
| 00817701026235 | InCore MPJ 2.8mm Drill Bit Sterile |
| 00817701026228 | InCore MPJ T8 Driver Sterile |
| 00817701026204 | InCore MPJ Replacement Compression Frame Right |
| 00817701026198 | InCore MPJ Replacement Compression Frame Left |
| 00817701026167 | InCore MPJ Torque Limiting Handle Reusable |
| 00817701026150 | InCore MPJ Depth Probe Reusable |
| 00817701026143 | InCore MPJ Removal Fastener Reusable |
| 00817701026136 | InCore MPJ Removal Drill Guide Reusable |
| 00817701026129 | InCore MPJ 2.8mm Drill Bit Reusable |
| 00817701026112 | InCore MPJ T8 Driver Reusable |
| 00817701026105 | InCore MPJ 4.9mm Post Drill Reusable |
| 00817701026099 | InCore MPJ Post Fastener Reusable |
| 00817701026082 | InCore MPJ Drill Bushing 70mm Reusable |
| 00817701026075 | InCore MPJ Drill Bushing 55mm Reusable |
| 00817701026068 | InCore MPJ Drill Bushing 40mm Reusable |
| 00817701026051 | InCore MPJ Replacement Compression Screw |
| 00817701026044 | InCore MPJ Targeting Guide Assembly Right Reusable |
| 00817701026037 | InCore MPJ Targeting Guide Assembly Left Reusable |
| 00817701026020 | InCore MPJ Post Guide Right Reusable |
| 00817701026013 | InCore MPJ Post Guide Left Reusable |
| 00817701026006 | InCore MPJ 4.9mm Post Plug Screw |
| 00817701025993 | InCore MPJ 2.7mm x 48mm Titanium Screw |
| 00817701025986 | InCore MPJ 2.7mm x 46mm Titanium Screw |
| 00817701025979 | InCore MPJ 2.7mm x 44mm Titanium Screw |
| 00817701025962 | InCore MPJ 2.7mm x 42mm Titanium Screw |
| 00817701025955 | InCore MPJ 2.7mm x 40mm Titanium Screw |
| 00817701025948 | InCore MPJ 2.7mm x 38mm Titanium Screw |
| 00817701025931 | InCore MPJ 2.7mm x 36mm Titanium Screw |
| 00817701025924 | InCore MPJ 2.7mm x 34mm Titanium Screw |
| 00817701025917 | InCore MPJ 2.7mm x 32mm Titanium Screw |
| 00817701025900 | InCore MPJ 2.7mm x 30mm Titanium Screw |
| 00817701025894 | InCore MPJ 2.7mm x 28mm Titanium Screw |
| 00817701025887 | InCore MPJ 2.7mm x 26mm Titanium Screw |
| 00817701025870 | InCore MPJ 2.7mm x 24mm Titanium Screw |
| 00817701025863 | InCore MPJ 2.7mm x 22mm Titanium Screw |
| 00817701025856 | InCore MPJ 2.7mm x 20mm Titanium Screw |
| 00817701025849 | InCore MPJ 2.7mm x 18mm Titanium Screw |
| 00817701025832 | InCore MPJ 2.7mm x 16mm Titanium Screw |
| 00817701025825 | InCore MPJ 4.9mm x 18mm Left Titanium Post |
| 00817701025818 | InCore MPJ 4.9mm x 18mm Right Titanium Post |