FDA.reportPublic FDA data

Invictus

Primary DI
00190376182865
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
15034-060-020
Device description
Uniplanar Screw, 6.0 X 20mm
Published
2021-08-05
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181677000Kodiak Spinal Fixation SystemAlphatec Spine, Inc.2018-08-09NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376182865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376182865001903761828651903761828650190376182865

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Outer Diameter6Millimeter

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
00840019978453Reform TiPRECISION SPINE, INC.KWP2026-11-04
00840019978460Reform TiPRECISION SPINE, INC.KWP2026-11-04
00840019978477Reform TiPRECISION SPINE, INC.KWP2026-11-04
00841732169371TAURUS LX Pedicle Screw SystemCTL Medical CorporationKWP2026-11-04
08800322699775AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800322699782AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800322699799AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800424704032AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800424704049AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08800424704056AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719654AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719661AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719678AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719685AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885719692AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885799939AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885799946AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809885799953AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974809969AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974809976AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974809983AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974809990AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03
08809974819920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWP2026-11-03