| Primary Device ID | 00817329024491 |
| NIH Device Record Key | e2e7934a-39e5-4cf6-a675-ecd489932212 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FacetLINK MI |
| Version Model Number | 80-2505 |
| Catalog Number | 80-2505 |
| Company DUNS | 067584601 |
| Company Name | LINKSPINE, 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 | 1-410-772-5465 |
| cs@linkspine.com | |
| Phone | 1-410-772-5465 |
| cs@linkspine.com | |
| Phone | 1-410-772-5465 |
| cs@linkspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817329024491 [Primary] |
| MRW | System, Facet Screw Spinal Device |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817329024491]
Moist Heat or Steam Sterilization
[00817329024491]
Moist Heat or Steam Sterilization
[00817329024491]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-27 |
| Device Publish Date | 2018-05-08 |
| 00817329025658 | FacetLINK MI Set |
| 00817329024927 | FacetLINK MI Tray |
| 00817329024606 | Facet Screw Driver Outer Tube |
| 00817329024576 | Jamshidi Needle |
| 00817329024569 | Cannulated Torque Handle |
| 00817329024552 | Reamer |
| 00817329024545 | Drill Stop |
| 00817329024538 | Drill |
| 00817329024521 | Facet Screw Screwdriver |
| 00817329024514 | Trocar Stylet |
| 00817329024507 | Trocar Stylet |
| 00817329024491 | Dilator Handle |
| 00817329024484 | Dilator 3 |
| 00817329024477 | Dilator 2 |
| 00817329024460 | Dilator 1 |