| Primary Device ID | 00817329023296 |
| NIH Device Record Key | e1e7210e-3c21-4d91-82ec-2c4c0d3874a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CorticaLINK MI |
| Version Model Number | 80-4728 |
| Catalog Number | 80-4728 |
| Company DUNS | 067584601 |
| Company Name | LINKSPINE, 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 | 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 | 00817329023296 [Primary] |
| KTZ | Caliper |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817329023296]
Moist Heat or Steam Sterilization
[00817329023296]
Moist Heat or Steam Sterilization
[00817329023296]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-28 |
| Device Publish Date | 2018-04-24 |
| 00817329025818 | CorticaLINK MI K-Wire Caddy |
| 00817329025641 | CorticaLINK MI Set |
| 00817329025122 | CL MI Guidewire Tube |
| 00817329025115 | CL MI Implant Tray 2 |
| 00817329025108 | CL MI Implant Tray 1 |
| 00817329025092 | CL MI Reduction Tray |
| 00817329025085 | CL MI Handles Tray |
| 00817329025078 | CL MI Insertion Instrument Tray |
| 00817329025061 | CL MI Prep Instrument Tray |
| 00817329025054 | Lag Screw Caddy |
| 00817329025047 | Added Rod Length Caddy |
| 00817329025030 | CLMI Tulip Wedge |
| 00817329025023 | CLMI Tissue Splitter, Small |
| 00817329025016 | Rod Length Indicator |
| 00817329025009 | Trocar Stylet |
| 00817329024996 | Stylet Handle |
| 00817329024804 | Set Screw Caddy |
| 00817329024644 | Counter Torque Reducer Insert |
| 00817329023470 | Reduction Assist |
| 00817329023463 | Reduction Cap Release |
| 00817329023456 | Large Reducer |
| 00817329023449 | Reduction Cap |
| 00817329023432 | Tulip Cap Release |
| 00817329023425 | Tulip Cap |
| 00817329023418 | Tab Breaker |
| 00817329023401 | Screw Head Adjuster |
| 00817329023395 | Final Tightener, C/D |
| 00817329023388 | Final Tightener |
| 00817329023371 | Compressor Distractor Handle |
| 00817329023364 | Compressor Distractor |
| 00817329023357 | Counter Torque Wrench |
| 00817329023340 | Counter Torque Sleeve |
| 00817329023333 | Offset Rod Inserter |
| 00817329023326 | Locking Cap Starter |
| 00817329023319 | Locking Cap Starter Anti-Splay |
| 00817329023302 | Tissue Splitter |
| 00817329023296 | Rod Caliper |
| 00817329023289 | Locking Screwdriver Inner Shaft |
| 00817329023272 | Locking Screwdriver |
| 00817329023265 | Guidewire, 500mm, Blunt |
| 00817329023258 | Guidewire, 500mm, Trocar |
| 00817329023241 | Dilator Handle |
| 00817329023234 | Dilator 3 |
| 00817329023227 | Dilator 2 |
| 00817329023210 | Dilator 1 |
| 00817329023180 | 5.0mm Cobalt Chrome Rod: 160mm Curved |
| 00817329023173 | 5.0mm Cobalt Chrome Rod: 150mm Curved |
| 00817329023166 | 5.0mm Cobalt Chrome Rod: 140mm Curved |
| 00817329023159 | 5.0mm Cobalt Chrome Rod: 130mm Curved |
| 00817329023142 | 5.0mm Titanium Rod: 160mm Curved |