FDA.reportPublic FDA data

Invictus

Primary DI
00190376305370
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
19010-50-38
Device description
FAVORED ANGLE SCREW, CC, 5.0mm X 38mm
Published
2021-03-31
Public version status
Update
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
00190376305370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376305370001903763053701903763053700190376305370

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length38Millimeter
Outer Diameter5Millimeter

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
00190376658933Valence Robotic Navigation System13010-Q-VN2026-10-29
00190376658940Valence Robotic Navigation System13010-VN2026-10-29
00190376659053Valence Robotic Navigation System13110-Q-VN2026-10-29
00190376729374Invictus Spinal Fixation System13603-01-VN2026-10-29
00190376729435Invictus Spinal Fixation System13613-01-VN2026-10-29
00190376749297Valence Robotic Navigation SystemVALPDP2026-10-29
00190376766140Valence Robotic Navigation SystemVNAVSUP2026-10-29
00190376776941Valence Robotic Navigation SystemV2MNVINN2026-10-29
00190376778358Valence Robotic Navigation SystemV2ONVINN2026-10-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322693902VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693919VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693926VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693933VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693940VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693957VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693964VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693971VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693988VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693995VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694008VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694015VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694022VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694039VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694046VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694053VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694060VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694077VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694084VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694091VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694107VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694114VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694121VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694138VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694145VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694152VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694169VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694176VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694183VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694190VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03