| Primary Device ID | 00840916129392 |
| NIH Device Record Key | 0937da7f-ec58-4f13-8ba2-2e7284d3bce6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Savannah-T |
| Version Model Number | 10710-1X45-50 |
| Company DUNS | 004022104 |
| Company Name | SPINAL ELEMENTS |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840916129392 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
[00840916129392]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-03 |
| Device Publish Date | 2017-09-13 |
| 00840916129415 | Savannah-T High Top Sinu-LOK, 2 Level x 27mm, 60mm length |
| 00840916129385 | Savannah-T High Top Sinu-LOK, 1 Level x 40mm, 45mm length |
| 00840916101114 | Savannah-T Curved Rod, 55mm |
| 00840916100452 | Savannah-T Straight Rod, 180 mm |
| 00840916100407 | Savannah-T Straight Rod, 140 mm |
| 00840916129521 | Sinu-Lok 5 Level x 30mm, 150mm L |
| 00840916129514 | Sinu-Lok 5 Level x 27mm, 140mm L |
| 00840916129507 | Sinu-Lok 4 Level x 31mm, 130mm L |
| 00840916129491 | Sinu-Lok 4 Level x 26mm, 120mm L |
| 00840916129484 | Sinu-Lok 4 Level x 26mm, 110mm L |
| 00840916129477 | Sinu-Lok 4 Level x 24mm, 90mm L |
| 00840916129460 | Sinu-Lok 3 Level x 28mm, 90mm L |
| 00840916129453 | Sinu-Lok 3 Level x 25mm, 80mm L |
| 00840916129446 | Sinu-Lok 2 Level x 35mm, 75mm L |
| 00840916129439 | Sinu-Lok 2 Level x 32mm, 70mm L |
| 00840916129422 | Sinu-Lok 2 Level x 30mm, 65mm L |
| 00840916129408 | Sinu-Lok 2 Level x 25mm, 55mm L |
| 00840916129392 | Sinu-Lok 1 Level x 45mm, 50mm L |
| 00840916129378 | Sinu-Lok 1 Level x 40mm, 45mm L |
| 00840916129361 | Sinu-Lok 1 Level x 29mm, 35mm L |
| 00840916117207 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 7.5 x 65mm (Clear) |
| 00840916117191 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 7.5 x 60mm (Clear) |
| 00840916117184 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 7.5 x 55mm (Clear) |
| 00840916117177 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 7.5 x 50mm (Clear) |
| 00840916117160 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 7.5 x 45mm (Clear) |
| 00840916117153 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 7.5 x 40mm (Clear) |
| 00840916117146 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 7.5 x 35mm (Clear) |
| 00840916117139 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 7.5 x 30mm (Clear) |
| 00840916117122 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 6.5 x 65mm (Clear) |
| 00840916117115 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 6.5 x 60mm (Clear) |
| 00840916117108 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 6.5 x 55mm (Clear) |
| 00840916117092 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 6.5 x 50mm (Clear) |
| 00840916117085 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 6.5 x 45mm (Clear) |
| 00840916117078 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 6.5 x 40mm (Clear) |
| 00840916117061 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 6.5 x 35mm (Clear) |
| 00840916117054 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 6.5 x 30mm (Clear) |
| 00840916117047 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 5.5 x 50mm (Clear) |
| 00840916117030 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 5.5 x 45mm (Clear) |
| 00840916117023 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 5.5 x 40mm (Clear) |
| 00840916117016 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 5.5 x 35mm (Clear) |
| 00840916117009 | Savannah-T Fluteless Low-Top Non-Cannulated Screw Assembly, 5.5 x 30mm (Clear) |
| 00840916116996 | Ø5.5 x 35mm, Savannah-T, Screw with Grip Quick Threads, Solid, Low-Top, Non-Fluted |
| 00840916116989 | Ø5.5 x 30mm, Savannah-T, Screw with Grip Quick Threads, Solid, Low-Top, Non-Fluted |
| 00840916116972 | Savannah-T Fluteless Low-Top Cannulated Screw Assembly, 7.5 x 65mm (Clear) |
| 00840916116965 | Savannah-T Fluteless Low-Top Cannulated Screw Assembly, 7.5 x 60mm (Clear) |
| 00840916116958 | Savannah-T Fluteless Low-Top Cannulated Screw Assembly, 7.5 x 55mm (Clear) |
| 00840916116941 | Savannah-T Fluteless Low-Top Cannulated Screw Assembly, 7.5 x 50mm (Clear) |
| 00840916116934 | Savannah-T Fluteless Low-Top Cannulated Screw Assembly, 7.5 x 45mm (Clear) |
| 00840916116927 | Savannah-T Fluteless Low-Top Cannulated Screw Assembly, 7.5 x 40mm (Clear) |
| 00840916116910 | Savannah-T Fluteless Low-Top Cannulated Screw Assembly, 7.5 x 35mm (Clear) |