| Primary Device ID | G079C5121850900 |
| NIH Device Record Key | 58347948-89b4-4048-9c31-bc8c151fe818 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Golden Isles Pedicle Screw System |
| Version Model Number | C51-2185-090 |
| Company DUNS | 037368183 |
| Company Name | Intelivation, 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 | 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 |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G079C5121850900 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
[G079C5121850900]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-03 |
| Device Publish Date | 2022-09-23 |
| G079C6050005640 | K-Wire Driver |
| G079C5121851100 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121851000 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850900 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850800 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850700 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850600 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850550 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850500 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850450 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850400 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850350 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850300 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121850250 | Ø8.5mm Dual Lead Cannulated Screw |
| G079C5121751100 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121751000 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750900 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750800 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750700 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750600 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750550 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750500 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750450 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750400 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750350 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750300 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121750250 | Ø7.5mm Dual Lead Cannulated Screw |
| G079C5121650600 | Ø6.5mm Dual Lead Cannulated Screw |
| G079C5121650550 | Ø6.5mm Dual Lead Cannulated Screw |
| G079C5121650500 | Ø6.5mm Dual Lead Cannulated Screw |
| G079C5121650450 | Ø6.5mm Dual Lead Cannulated Screw |
| G079C5121650400 | Ø6.5mm Dual Lead Cannulated Screw |
| G079C5121650350 | Ø6.5mm Dual Lead Cannulated Screw |
| G079C5121650300 | Ø6.5mm Dual Lead Cannulated Screw |
| G079C5121650250 | Ø6.5mm Dual Lead Cannulated Screw |
| G079C5121550600 | Ø5.5mm Dual Lead Cannulated Screw |
| G079C5121550550 | Ø5.5mm Dual Lead Cannulated Screw |
| G079C5121550500 | Ø5.5mm Dual Lead Cannulated Screw |
| G079C5121550450 | Ø5.5mm Dual Lead Cannulated Screw |
| G079C5121550400 | Ø5.5mm Dual Lead Cannulated Screw |
| G079C5121550350 | Ø5.5mm Dual Lead Cannulated Screw |
| G079C5121550300 | Ø5.5mm Dual Lead Cannulated Screw |
| G079C5121550250 | Ø5.5mm Dual Lead Cannulated Screw |
| G079C5120851100 | Ø8.5mm Dual Lead Screw |
| G079C5120851000 | Ø8.5mm Dual Lead Screw |
| G079C5120850900 | Ø8.5mm Dual Lead Screw |
| G079C5120850800 | Ø8.5mm Dual Lead Screw |
| G079C5120850700 | Ø8.5mm Dual Lead Screw |
| G079C5120850600 | Ø8.5mm Dual Lead Screw |
| G079C5120850550 | Ø8.5mm Dual Lead Screw |