Invictus
GUDID 00190376458168
SI.Core Fenestrated Closed Favored Angle Screw, 12.5mm X 65mm
ALPHATEC SPINE, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00190376458168 |
| NIH Device Record Key | 1d1ab923-8e54-4258-a91a-e5058875fe36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invictus |
| Version Model Number | 55475-125-065 |
| 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 |
Customer Support Contacts
Device Dimensions
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 65 Millimeter |
| Outer Diameter | 12.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376458168 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K214006
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
[00190376458168]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-30 |
| Device Publish Date | 2022-05-20 |
On-Brand Devices [Invictus]
| 00190376240664 | Pedicle Hook, 12.5mm |
| 00190376240657 | Pedicle Hook, 11.5mm |
| 00190376234168 | Open-Closed Revision Connector, 14mm |
| 00190376234151 | Open-Closed Revision Connector, 13mm |
| 00190376234144 | Open-Closed Revision Connector, 12mm |
| 00190376234137 | Open-Closed Revision Connector, 11mm |
| 00190376234120 | Closed-Side Loading Revision Connector, 18mm |
| 00190376234113 | Closed-Side Loading Revision Connector, 17mm |
| 00190376234106 | Closed-Side Loading Revision Connector, 16mm |
| 00190376234090 | Closed-Side Loading Revision Connector, 15mm |
| 00190376234083 | Closed-Side Loading Revision Connector, 14mm |
| 00190376234076 | Closed-Side Loading Revision Connector, 13mm |
| 00190376234069 | Closed-Side Loading Revision Connector, 12mm |
| 00190376234052 | Closed-Side Loading Revision Connector, 11mm |
| 00190376234045 | Open-Closed Revision Connector, 18mm |
| 00190376234038 | Open-Closed Revision Connector, 17mm |
| 00190376234021 | Open-Closed Revision Connector, 16mm |
| 00190376234014 | Open-Closed Revision Connector, 15mm |
| 00190376233598 | Angled Hook, Left, Long, 12.5mm |
| 00190376233581 | Angled Hook, Left, Long, 11.5mm |
| 00190376233574 | Angled Hook, Left, Long, 10.5mm |
| 00190376233567 | Angled Hook, Left, Long, 9.5mm |
| 00190376233550 | Angled Hook, Left, Long, 8.5mm |
| 00190376233543 | Angled Hook, Left, Long, 7.5mm |
| 00190376233536 | Angled Hook, Left, Long, 6.5mm |
| 00190376233529 | Angled Hook, Left, Long, 5.5mm |
| 00190376233512 | Angled Hook, Left, 12.5mm |
| 00190376233505 | Angled Hook, Left, 11.5mm |
| 00190376233499 | Angled Hook, Left, 10.5mm |
| 00190376233482 | Angled Hook, Left, 9.5mm |
| 00190376233475 | Angled Hook, Left, 8.5mm |
| 00190376233321 | Offset Hook, Right, 12.5mm |
| 00190376233314 | Offset Hook, Right, 11.5mm |
| 00190376233307 | Offset Hook, Right, 10.5mm |
| 00190376233291 | Offset Hook, Right, 9.5mm |
| 00190376233284 | Offset Hook, Right, 8.5mm |
| 00190376233277 | Offset Hook, Right, 7.5mm |
| 00190376233260 | Offset Hook, Right, 6.5mm |
| 00190376233253 | Offset Hook, Right, 5.5mm |
| 00190376233246 | Angled Hook, Left, 7.5mm |
| 00190376233239 | Angled Hook, Left, 6.5mm |
| 00190376233222 | Angled Hook, Left, 5.5mm |
| 00190376233055 | Angled Hook, Right, Long, 12.5mm |
| 00190376233048 | Angled Hook, Right, Long, 11.5mm |
| 00190376233031 | Angled Hook, Right, Long, 10.5mm |
| 00190376233024 | Angled Hook, Right, Long, 9.5mm |
| 00190376233017 | Angled Hook, Right, Long, 8.5mm |
| 00190376233000 | Angled Hook, Right, Long, 7.5mm |
| 00190376232997 | Angled Hook, Right, Long, 6.5mm |
| 00190376232980 | Angled Hook, Right, Long, 5.5mm |
Trademark Results [Invictus]
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