FDA.reportPublic FDA data

Invictus

Primary DI
00190376507408
Brand
Invictus
Company
ALPHATEC SPINE, INC.
Model
15023-125-050
Device description
Cannulated Cortical-Cancellous Extended Tab Polyaxial Reduction Screw Ø12.5mm x 50mm
Published
2023-04-19
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
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221926000Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.2022-12-20PML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376507408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376507408001903765074081903765074080190376507408

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Outer Diameter12.5Millimeter

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
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
00190376732015Segmental Plating System338-0215-S2026-07-27
00190376732022Segmental Plating System338-0216-S2026-07-27
00190376732039Segmental Plating System338-0217-S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCNKB2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28