| Primary Device ID | 03607503507219 |
| NIH Device Record Key | 8e82e870-e93a-4f6f-830a-c0c8f4580f64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JAZZ FRAME |
| Version Model Number | JAZZ Frame – T-Bar |
| Catalog Number | 350721 |
| Company DUNS | 291993439 |
| Company Name | IMPLANET |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03607503507219 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-09-26 |
| Device Publish Date | 2017-01-24 |
| 03607503507554 | JAZZ Frame – Straight Rod Dia. 6.0 L600 |
| 03607503507547 | JAZZ Frame – Straight Rod Dia. 6.0 L500 |
| 03607503507530 | JAZZ Frame – Straight Rod L 600 CoCr |
| 03607503507523 | JAZZ Frame – Straight Rod L 500 CoCr |
| 03607503507516 | JAZZ Frame – Straight Rod L 600 |
| 03607503507509 | JAZZ Frame – Straight Rod L 500 |
| 03607503507271 | JAZZ Frame - T-Bar Dia.4,5 L25 |
| 03607503507233 | JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L35 |
| 03607503507226 | JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L30 |
| 03607503507219 | JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L25 |
| 03607503507295 | JAZZ Frame - T-Bar Dia.4,5 L35 |
| 03607503507288 | JAZZ Frame - T-Bar Dia.4,5 L30 |