| Primary Device ID | 00814729025394 |
| NIH Device Record Key | cea0401e-d2c1-4113-bad2-d9df6082a59a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InFill Contour TLIF |
| Version Model Number | 43-05-103008 |
| Company DUNS | 962347980 |
| Company Name | PINNACLE SPINE GROUP, LLC |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814729025394 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814729025394]
Radiation Sterilization;Moist Heat or Steam Sterilization
[00814729025394]
Radiation Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-08-26 |
| 00814729025479 | 43-05-103016 |
| 00814729025462 | 43-05-103015 |
| 00814729025455 | 43-05-103014 |
| 00814729025448 | 43-05-103013 |
| 00814729025431 | 43-05-103012 |
| 00814729025424 | 43-05-103011 |
| 00814729025417 | 43-05-103010 |
| 00814729025400 | 43-05-103009 |
| 00814729025394 | 43-05-103008 |
| 00814729025387 | 43-05-102616 |
| 00814729025370 | 43-05-102615 |
| 00814729025363 | 43-05-102614 |
| 00814729025356 | 43-05-102613 |
| 00814729025349 | 43-05-102612 |
| 00814729025332 | 43-05-102611 |
| 00814729025325 | 43-05-102610 |
| 00814729025318 | 43-05-102609 |
| 00814729025301 | 43-05-102608 |