| Primary Device ID | 00811954013332 |
| NIH Device Record Key | 827d6c16-a983-4a78-a202-6abc081ce04c |
| Commercial Distribution Discontinuation | 2016-12-23 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | 8 Degree Lordotic, Opticage Expandable Interbody Implant |
| Version Model Number | 9101-10 |
| Catalog Number | 9101-10 |
| Company DUNS | 017663522 |
| Company Name | INTERVENTIONAL SPINE, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811954013332 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-05-25 |
| 00811954013462 | 22mm Width x 55mm Length by 11mm-16mm Footprint Length |
| 00811954013455 | 22mm Width x 50mm Length by 11mm-16mm Footprint Length |
| 00811954013431 | 22mm Width x 40mm Length by 11mm-16mm Footprint Length |
| 00811954013424 | 18mm Width x 55mm Length by 11mm-16mm Footprint Length |
| 00811954013417 | 18mm Width x 50mm Length by 11mm-16mm Footprint Length |
| 00811954013400 | 18mm Width x 45mm Length by 11mm-16mm Footprint Length |
| 00811954013394 | 18mm Width x 40mm Length by 11mm-16mm Footprint Length |
| 00811954013387 | 16mm Width x 55mm Length by 11mm-16mm Footprint Length |
| 00811954013370 | 16mm Width x 50mm Length by 11mm-16mm Footprint Length |
| 00811954013363 | 16mm Width x 45mm Length by 11mm-16mm Footprint Length |
| 00811954013356 | 16mm Width x 40mm Length by 11mm-16mm Footprint Length |
| 00811954013349 | 12mm Width x 30mm Length by 11mm-16mm Footprint Length |
| 00811954013332 | 12mm Width x 26mm Length by 11mm-16mm Footprint Length |
| 00811954013325 | 12mm Width x 21mm Length by 11mm-16mm Footprint Length |
| 00811954013318 | 11mm Width x 30mm Length by 11mm-16mm Footprint Length |
| 00811954013301 | 11mm Width x 26mm Length by 11mm-16mm Footprint Length |
| 00811954013295 | 11mm Width x 21mm Length by 11mm-16mm Footprint Length |
| 00811954013288 | 10mm Width x 30mm Length by 11mm-16mm Footprint Length |
| 00811954013271 | 10mm Width x 26mm Length by 11mm-16mm Footprint Length |
| 00811954013264 | 10mm Width x 21mm Length by 11mm-16mm Footprint Length |
| 00811954013257 | 9mm Width x 30mm Length by 11mm-16mm Footprint Length |
| 00811954013240 | 9mm Width x 26mm Length by 11mm-16mm Footprint Length |
| 00811954013233 | 9mm Width x 21mm Length by 11mm-16mm Footprint Length |
| 00011954013448 | 22mm Width x 45mm Length by 11mm-16mm Footprint Length |