Insignia

GUDID 00190376330440

4.5mm Fixed Angle, Self-Drilling Screw, Single Lead 22mm

ALPHATEC SPINE, INC.

Spinal bone screw, non-bioabsorbable
Primary Device ID00190376330440
NIH Device Record Key02fd8dc7-11b0-4895-997a-8b3076836bb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsignia
Version Model Number236-1-44522
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376330440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


[00190376330440]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-11
Device Publish Date2023-12-03

On-Brand Devices [Insignia]

0019037627473720° Trial Drill Guide, 12mm
0019037627472020° Trial Drill Guide, 11mm
0019037627471320° Trial Drill Guide, 10mm
0019037627470620° Trial Drill Guide, 9mm
0019037627469020° Trial Drill Guide, 8mm
0019037627468320° Trial Drill Guide, 7mm
0019037627467620° Trial Drill Guide, 6mm
0019037627466920° Trial Drill Guide, 5mm
0019037627465215° Trial Drill Guide, 12mm
0019037627464515° Trial Drill Guide, 11mm
0019037627463815° Trial Drill Guide, 10mm
0019037627462115° Trial Drill Guide, 9mm
0019037627461415° Trial Drill Guide, 8mm
0019037627460715° Trial Drill Guide, 7mm
0019037627459115° Trial Drill Guide, 6mm
0019037627458415° Trial Drill Guide, 5mm
0019037627457712° Trial Drill Guide, 12mm
0019037627456012° Trial Drill Guide, 11mm
0019037627455312° Trial Drill Guide, 10mm
0019037627454612° Trial Drill Guide, 9mm
0019037627453912° Trial Drill Guide, 8mm
0019037627452212° Trial Drill Guide, 7mm
0019037627451512° Trial Drill Guide, 6mm
0019037627450812° Trial Drill Guide, 5mm
0019037627449210° Trial Drill Guide, 12mm
0019037627448510° Trial Drill Guide, 11mm
0019037627447810° Trial Drill Guide, 10mm
0019037627446110° Trial Drill Guide, 9mm
0019037627445410° Trial Drill Guide, 8mm
0019037627444710° Trial Drill Guide, 7mm
0019037627443010° Trial Drill Guide, 6mm
0019037627442310° Trial Drill Guide, 5mm
00190376274416Quad Barrel Trial Drill Guide, 12mm
00190376274409Quad Barrel Trial Drill Guide, 11mm
00190376274393Quad Barrel Trial Drill Guide, 10mm
00190376274386Quad Barrel Trial Drill Guide, 9mm
00190376274379Quad Barrel Trial Drill Guide, 8mm
00190376274362Quad Barrel Trial Drill Guide, 7mm
00190376274355Quad Barrel Trial Drill Guide, 6mm
00190376274348Quad Barrel Trial Drill Guide, 5mm
00190376271040Single Level Inserter
00190376268743Insignia, ACP, 1-Level, 24 mm
00190376268491Insignia, ACP, 1-Level, 23 mm
00190376268484Insignia, ACP, 1-Level, 22 mm
00190376268477Insignia, ACP, 1-Level, 21 mm
00190376268460Insignia, ACP, 1-Level, 20 mm
00190376268453Insignia, ACP, 1-Level, 19 mm
00190376268446Insignia, ACP, 1-Level, 18 mm
00190376268439Insignia, ACP, 1-Level, 17 mm
00190376268422Insignia, ACP, 1-Level, 16 mm

Trademark Results [Insignia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSIGNIA
INSIGNIA
98152847 not registered Live/Pending
Stylish Associates LLC
2023-08-28
INSIGNIA
INSIGNIA
98152845 not registered Live/Pending
Stylish Associates LLC
2023-08-28
INSIGNIA
INSIGNIA
98063462 not registered Live/Pending
GARCIA HUGO C
2023-06-28
INSIGNIA
INSIGNIA
98063462 not registered Live/Pending
GARCIA, ROBERTO C
2023-06-28
INSIGNIA
INSIGNIA
97847346 not registered Live/Pending
Jayco, Inc.
2023-03-20
INSIGNIA
INSIGNIA
97813239 not registered Live/Pending
Cardenas-Cuevas, Alejandro
2023-02-27
INSIGNIA
INSIGNIA
97749310 not registered Live/Pending
Garcia, Hugo C
2023-01-10
INSIGNIA
INSIGNIA
97269684 not registered Live/Pending
JACKSON NEW YORK LLC
2022-02-16
INSIGNIA
INSIGNIA
90590493 not registered Live/Pending
Jackson Stack
2021-03-19
INSIGNIA
INSIGNIA
90568019 not registered Live/Pending
LMK TECHNOLOGIES, LLC
2021-03-09
INSIGNIA
INSIGNIA
90207288 not registered Live/Pending
BBY Solutions, Inc.
2020-09-24
INSIGNIA
INSIGNIA
90149626 not registered Live/Pending
SpeeDx Pty Ltd
2020-08-31

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