FDA.reportPublic FDA data

Insignia

Primary DI
00190376330440
Brand
Insignia
Company
ALPHATEC SPINE, INC.
Model
236-1-44522
Device description
4.5mm Fixed Angle, Self-Drilling Screw, Single Lead 22mm
Published
2023-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213443000Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2021-12-15KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376330440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376330440001903763304401903763304400190376330440

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376778372InvictusVMRIN2026-08-19
00190376778396InvictusVMTIN2026-08-19
00190376768847Invictus171442026-08-17
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30
00190376544434Invictus17920-052026-07-30
00190376544441Invictus17920-062026-07-30
00190376544458Invictus17920-072026-07-30
00190376544465Invictus17920-082026-07-30
00190376544472Invictus17920-092026-07-30
00190376544489Invictus17920-102026-07-30
00190376544496Invictus179212026-07-30
00190376544502Invictus179222026-07-30
00190376544519Invictus179242026-07-30
00190376544861Invictus17920-112026-07-30
00190376544878Invictus17920-122026-07-30
00190376766133InvictusVMDCORT2026-07-30
00190376732008Segmental Plating System338-0214-S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWQ2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWQ2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24