| Primary Device ID | 00840967116532 |
| NIH Device Record Key | 6916d730-61b1-4452-8479-e9d50f3aacac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arsenal Deformity Spinal Fixation System |
| Version Model Number | 48700-015-085-030 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Angle | 15 degree |
| Length | 30 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840967116532 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
[00840967116532]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-30 |
| Device Publish Date | 2016-04-27 |
| 00190376006147 | Rod Connector, Closed 5.5mm Side-Loading 6.35mm |
| 00190376006130 | Rod Connector, Closed 5.5mm Side-Loading 5.5 |
| 00840967116945 | ILIAC BOLT, 15 DEGREE, 9.0mm X 130mm |
| 00840967116938 | ILIAC BOLT, 15 DEGREE, 9.0mm X 125mm |
| 00840967116921 | ILIAC BOLT, 15 DEGREE, 9.0mm X 120mm |
| 00840967116914 | ILIAC BOLT, 15 DEGREE, 9.0mm X 115mm |
| 00840967116907 | ILIAC BOLT, 15 DEGREE, 9.0mm X 110mm |
| 00840967116891 | ILIAC BOLT, 15 DEGREE, 9.0mm X 105mm |
| 00840967116884 | ILIAC BOLT, 15 DEGREE, 9.0mm X 100mm |
| 00840967116877 | ILIAC BOLT, 15 DEGREE, 9.0mm X 95mm |
| 00840967116860 | ILIAC BOLT, 15 DEGREE, 9.0mm X 90mm |
| 00840967116853 | Iliac Bolt, 15°, 9.0mm X 90mm |
| 00840967116846 | ILIAC BOLT, 15 DEGREE, 9.0mm X 80mm |
| 00840967116839 | Iliac Bolt, 15°, 9.0mm X 80mm |
| 00840967116822 | ILIAC BOLT, 15 DEGREE, 9.0mm X 70mm |
| 00840967116815 | Iliac Bolt, 15°, 9.0mm X 70mm |
| 00840967116808 | ILIAC BOLT, 15 DEGREE, 9.0mm X 60mm |
| 00840967116792 | Iliac Bolt, 15°, 9.0mm X 60mm |
| 00840967116785 | Iliac Bolt, 15°, 9.0mm X 55mm |
| 00840967116778 | ILIAC BOLT, 15 DEGREE, 9.0mm X 45mm |
| 00840967116761 | Iliac Bolt, 15°, 9.0mm X 45mm |
| 00840967116754 | Iliac Bolt, 15°, 9.0mm X 40mm |
| 00840967116747 | Iliac Bolt, 15°, 9.0mm X 35mm |
| 00840967116730 | ILIAC BOLT, 15 DEGREE, 8.5mm X 130mm |
| 00840967116723 | Iliac Bolt, 15°, 8.5mm X 130mm |
| 00840967116716 | Iliac Bolt, 15°, 8.5mm X 125mm |
| 00840967116709 | Iliac Bolt, 15°, 8.5mm X 120mm |
| 00840967116693 | Iliac Bolt, 15°, 8.5mm X 115mm |
| 00840967116686 | Iliac Bolt, 15°, 8.5mm X 110mm |
| 00840967116679 | Iliac Bolt, 15°, 8.5mm X 105mm |
| 00840967116662 | ILIAC BOLT, 15 DEGREE, 8.5mm X 95mm |
| 00840967116655 | Iliac Bolt, 15°, 8.5mm X 95mm |
| 00840967116648 | Iliac Bolt, 15°, 8.5mm X 90mm |
| 00840967116631 | Iliac Bolt, 15°, 8.5mm X 85mm |
| 00840967116624 | Iliac Bolt, 15°, 8.5mm X 80mm |
| 00840967116617 | Iliac Bolt, 15°, 8.5mm X 75mm |
| 00840967116600 | Iliac Bolt, 15°, 8.5mm X 70mm |
| 00840967116594 | Iliac Bolt, 15°, 8.5mm X 65mm |
| 00840967116587 | ILIAC BOLT, 15 DEGREE, 8.5mm X 55mm |
| 00840967116570 | ILIAC BOLT, 15 DEGREE, 8.5mm X 50mm |
| 00840967116563 | ILIAC BOLT, 15 DEGREE, 8.5mm X 45mm |
| 00840967116556 | ILIAC BOLT, 15 DEGREE, 8.5mm X 40mm |
| 00840967116549 | ILIAC BOLT, 15 DEGREE, 8.5mm X 35mm |
| 00840967116532 | ILIAC BOLT, 15 DEGREE, 8.5mm X 30mm |
| 00840967116525 | ILIAC BOLT, 15 DEGREE, 8.0mm X 130mm |
| 00840967116518 | ILIAC BOLT, 15 DEGREE, 8.0mm X 125mm |
| 00840967116501 | ILIAC BOLT, 15 DEGREE, 8.0mm X 120mm |
| 00840967116495 | ILIAC BOLT, 15 DEGREE, 8.0mm X 115mm |
| 00840967116488 | ILIAC BOLT, 15 DEGREE, 8.0mm X 110mm |
| 00840967116471 | ILIAC BOLT, 15 DEGREE, 8.0mm X 105mm |