Insignia
GUDID 00190376329864
4.5mm Fixed Angle, Self-Tapping Screw, Single Lead 12mm
ALPHATEC SPINE, INC.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00190376329864 |
| NIH Device Record Key | db019ae9-3825-486c-b917-a29931beb3b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insignia |
| Version Model Number | 236-1-34512 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376329864 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213443
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
[00190376329864]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-18 |
| Device Publish Date | 2022-03-10 |
On-Brand Devices [Insignia]
| 00190376274737 | 20° Trial Drill Guide, 12mm |
| 00190376274720 | 20° Trial Drill Guide, 11mm |
| 00190376274713 | 20° Trial Drill Guide, 10mm |
| 00190376274706 | 20° Trial Drill Guide, 9mm |
| 00190376274690 | 20° Trial Drill Guide, 8mm |
| 00190376274683 | 20° Trial Drill Guide, 7mm |
| 00190376274676 | 20° Trial Drill Guide, 6mm |
| 00190376274669 | 20° Trial Drill Guide, 5mm |
| 00190376274652 | 15° Trial Drill Guide, 12mm |
| 00190376274645 | 15° Trial Drill Guide, 11mm |
| 00190376274638 | 15° Trial Drill Guide, 10mm |
| 00190376274621 | 15° Trial Drill Guide, 9mm |
| 00190376274614 | 15° Trial Drill Guide, 8mm |
| 00190376274607 | 15° Trial Drill Guide, 7mm |
| 00190376274591 | 15° Trial Drill Guide, 6mm |
| 00190376274584 | 15° Trial Drill Guide, 5mm |
| 00190376274577 | 12° Trial Drill Guide, 12mm |
| 00190376274560 | 12° Trial Drill Guide, 11mm |
| 00190376274553 | 12° Trial Drill Guide, 10mm |
| 00190376274546 | 12° Trial Drill Guide, 9mm |
| 00190376274539 | 12° Trial Drill Guide, 8mm |
| 00190376274522 | 12° Trial Drill Guide, 7mm |
| 00190376274515 | 12° Trial Drill Guide, 6mm |
| 00190376274508 | 12° Trial Drill Guide, 5mm |
| 00190376274492 | 10° Trial Drill Guide, 12mm |
| 00190376274485 | 10° Trial Drill Guide, 11mm |
| 00190376274478 | 10° Trial Drill Guide, 10mm |
| 00190376274461 | 10° Trial Drill Guide, 9mm |
| 00190376274454 | 10° Trial Drill Guide, 8mm |
| 00190376274447 | 10° Trial Drill Guide, 7mm |
| 00190376274430 | 10° Trial Drill Guide, 6mm |
| 00190376274423 | 10° Trial Drill Guide, 5mm |
| 00190376274416 | Quad Barrel Trial Drill Guide, 12mm |
| 00190376274409 | Quad Barrel Trial Drill Guide, 11mm |
| 00190376274393 | Quad Barrel Trial Drill Guide, 10mm |
| 00190376274386 | Quad Barrel Trial Drill Guide, 9mm |
| 00190376274379 | Quad Barrel Trial Drill Guide, 8mm |
| 00190376274362 | Quad Barrel Trial Drill Guide, 7mm |
| 00190376274355 | Quad Barrel Trial Drill Guide, 6mm |
| 00190376274348 | Quad Barrel Trial Drill Guide, 5mm |
| 00190376271040 | Single Level Inserter |
| 00190376268743 | Insignia, ACP, 1-Level, 24 mm |
| 00190376268491 | Insignia, ACP, 1-Level, 23 mm |
| 00190376268484 | Insignia, ACP, 1-Level, 22 mm |
| 00190376268477 | Insignia, ACP, 1-Level, 21 mm |
| 00190376268460 | Insignia, ACP, 1-Level, 20 mm |
| 00190376268453 | Insignia, ACP, 1-Level, 19 mm |
| 00190376268446 | Insignia, ACP, 1-Level, 18 mm |
| 00190376268439 | Insignia, ACP, 1-Level, 17 mm |
| 00190376268422 | Insignia, ACP, 1-Level, 16 mm |
Trademark Results [Insignia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSIGNIA 98152847 not registered Live/Pending |
Stylish Associates LLC 2023-08-28 |
 INSIGNIA 98152845 not registered Live/Pending |
Stylish Associates LLC 2023-08-28 |
 INSIGNIA 98063462 not registered Live/Pending |
GARCIA HUGO C 2023-06-28 |
INSIGNIA 98063462 not registered Live/Pending |
GARCIA, ROBERTO C 2023-06-28 |
 INSIGNIA 97847346 not registered Live/Pending |
Jayco, Inc. 2023-03-20 |
 INSIGNIA 97813239 not registered Live/Pending |
Cardenas-Cuevas, Alejandro 2023-02-27 |
 INSIGNIA 97749310 not registered Live/Pending |
Garcia, Hugo C 2023-01-10 |
 INSIGNIA 97269684 not registered Live/Pending |
JACKSON NEW YORK LLC 2022-02-16 |
 INSIGNIA 90590493 not registered Live/Pending |
Jackson Stack 2021-03-19 |
 INSIGNIA 90568019 not registered Live/Pending |
LMK TECHNOLOGIES, LLC 2021-03-09 |
 INSIGNIA 90207288 not registered Live/Pending |
BBY Solutions, Inc. 2020-09-24 |
 INSIGNIA 90149626 not registered Live/Pending |
SpeeDx Pty Ltd 2020-08-31 |
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