FDA.reportPublic FDA data

Invictus

Primary DI
00190376649108
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
18030-55-40
Device description
POLYAXIAL REDUCTION SCREW, 5.5mm X 40mm
Published
2025-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203125000Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.2020-12-18NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376649108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376649108001903766491081903766491080190376649108

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended 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 (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter
Outer Diameter5.5Millimeter

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
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376632919Invictus19869-N2026-10-20
00840967110981AlphaGRAFT1002-1002015-09-24
00840967110998AlphaGRAFT1001-0102015-09-24
00840967111001AlphaGRAFT1001-1002015-09-24
00844856026711AlphaGRAFT1001-0502015-09-24
00844856026728AlphaGRAFT1002-0252015-09-24
00844856026735AlphaGRAFT1002-0502015-09-24
00844856032231Osseofix +213902016-10-28
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25
00190376652337CONTOUR3DAIX761042026-09-25
00190376668307CONTOUR3DAIX760002026-09-25
00190376733470CONTOUR3DC3DRODA2026-09-25
00190376778372InvictusVMRIN2026-08-19
00190376778396InvictusVMTIN2026-08-19
00190376768847Invictus171442026-08-17
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322693100VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693117VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693124VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693131VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693148VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693155VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693162VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693179VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693186VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693193VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693209VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693216VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693223VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693230VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693247VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693254VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693261VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693278VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693285VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693292VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693308VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693315VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693322VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693339VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693346VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693353VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693360VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693377VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693384VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693391VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30