| Primary Device ID | 00190376349299 |
| NIH Device Record Key | 7a154824-e877-471f-895e-75f6438881b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invictus OsseoScrew |
| Version Model Number | 17905-075 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376349299 [Primary] |
| HWX | TAP, BONE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
[00190376349299]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-23 |
| Device Publish Date | 2021-12-15 |
| 00190376307350 | Osseoscrew Ratcheting Egg Handle, Cannulated |
| 00190376307343 | Osseoscrew, Collapse Handle |
| 00190376307336 | Invictus Osseoscrew, Expansion Shaft, 55 mm |
| 00190376307329 | Invictus Osseoscrew, Expansion Shaft, 50 mm |
| 00190376307312 | Invictus Osseoscrew, Expansion Shaft, 45 mm |
| 00190376307305 | Invictus Osseoscrew, Expansion Shaft, 40 mm |
| 00190376301709 | Osseoscrew Trial Probe, Right, Cannulated |
| 00190376301693 | Osseoscrew Trial Probe, Left, Cannulated |
| 00190376301686 | Osseoscrew Expansion T Handle |
| 00190376301679 | Osseoscrew Trial Marker, Right |
| 00190376301662 | Osseoscrew Trial Marker, Left |
| 00190376244549 | Invictus Osseoscrew, Extended Tab, 7.5 X 55mm |
| 00190376244532 | Invictus Osseoscrew, Extended Tab, 7.5 X 50mm |
| 00190376244525 | Invictus Osseoscrew, Extended Tab, 7.5 X 45mm |
| 00190376244518 | Invictus Osseoscrew, Extended Tab, 7.5 X 40mm |
| 00190376244402 | Invictus Osseoscrew, Extended Tab, 6.5 X 55mm |
| 00190376244396 | Invictus Osseoscrew, Extended Tab, 6.5 X 50mm |
| 00190376244389 | Invictus Osseoscrew, Extended Tab, 6.5 X 45mm |
| 00190376244372 | Invictus Osseoscrew, Extended Tab, 6.5 X 40mm |
| 00190376244242 | Invictus Osseoscrew, Reduction, 7.5 X 55mm |
| 00190376244235 | Invictus Osseoscrew, Reduction, 7.5 X 50mm |
| 00190376244228 | Invictus Osseoscrew, Reduction, 7.5 X 45mm |
| 00190376244211 | Invictus Osseoscrew, Reduction, 7.5 X 40mm |
| 00190376244105 | Invictus Osseoscrew, Reduction, 6.5 X 55mm |
| 00190376244099 | Invictus Osseoscrew, Reduction, 6.5 X 50mm |
| 00190376244082 | Invictus Osseoscrew, Reduction, 6.5 X 45mm |
| 00190376244075 | Invictus Osseoscrew, Reduction, 6.5 X 40mm |
| 00190376243962 | Invictus Osseoscrew, Polyaxial, 7.5 X 55mm |
| 00190376243887 | Invictus Osseoscrew, Polyaxial, 7.5 X 50mm |
| 00190376243870 | Invictus Osseoscrew, Polyaxial, 7.5 X 45mm |
| 00190376243863 | Invictus Osseoscrew, Polyaxial, 7.5 X 40mm |
| 00190376243849 | Invictus Osseoscrew, Polyaxial, 6.5 X 55mm |
| 00190376243832 | Invictus Osseoscrew, Polyaxial, 6.5 X 50mm |
| 00190376243825 | Invictus Osseoscrew, Polyaxial, 6.5 X 45mm |
| 00190376243818 | Invictus Osseoscrew, Polyaxial, 6.5 X 40mm |
| 00190376381657 | Invictus Osseoscrew, Expansion Shaft 55mm |
| 00190376381640 | Invictus Osseoscrew, Expansion Shaft 50mm |
| 00190376381633 | Invictus Osseoscrew, Expansion Shaft 45mm |
| 00190376381626 | Invictus Osseoscrew, Expansion Shaft 40mm |
| 00190376381725 | Invictus Osseoscrew, Expansion Shaft 55mm |
| 00190376381701 | Invictus Osseoscrew, Expansion Shaft 50mm |
| 00190376381688 | Invictus Osseoscrew, Expansion Shaft 45mm |
| 00190376381664 | Invictus Osseoscrew, Expansion Shaft 40mm |
| 00190376349299 | Invictus Osseoscrew Tap, 7.5mm, Cannulated |
| 00190376349282 | Invictus Osseoscrew Tap, 6.5mm, Cannulated |
| 00190376349275 | Invictus Osseoscrew Tap, 5.5mm, Cannulated |
| 00190376349268 | Osseoscrew, Collapse Handle |
| 00190376349251 | Osseoscrew Trial Probe, Right, Cannulated |
| 00190376349244 | Osseoscrew Trial Probe, Left, Cannulated |
| 00190376349237 | Osseoscrew Expansion T Handle |