FDA.reportPublic FDA data

AxTiHA®

Primary DI
M711AXTI65350
Brand
AxTiHA®
Company
INNO Holdings, Inc.
Model
AXTi6535
Catalog number
AXTi6535
Device description
Ti 6Al 4V (ELI)
Published
2026-03-31
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
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250603000AxTiHA® Stand-Alone ALIF SystemInnovasis2025-03-24OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711AXTI65350PrimaryHIBCC0

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
Length35Millimeter
Outer Diameter6.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711LB0720L-Box®LB-072LB-0722019-07-05
M711LB0730L-Box®LB-073LB-0732019-07-05
M711LB1340L-Box®LB-134LB-1342019-07-05
M711LB1350L-Box®LB-135LB-1352019-07-05
M711LS5530TruView™LS-5532022-03-31
M711511409070Endeavor™ Stand-Alone Cervical51-1409072026-05-01
M71151010Endeavor™ Stand-Alone Cervical51-012026-04-30
M711511406070Endeavor™ Stand-Alone Cervical51-1406072026-04-30
M711511407070Endeavor™ Stand-Alone Cervical51-1407072026-04-30
M711511407120Endeavor™ Stand-Alone Cervical51-1407122026-04-30
M711511408070Endeavor™ Stand-Alone Cervical51-1408072026-04-30
M711511408120Endeavor™ Stand-Alone Cervical51-1408122026-04-30
M711511409120Endeavor™ Stand-Alone Cervical51-1409122026-04-30
M711AXTI55350AxTiHA®AXTi5535AXTi55352026-03-31
M711AXTI55400AxTiHA®AXTi5540AXTi55402026-03-31
M711AXTI65400AxTiHA®AXTi6540AXTi65402026-03-31
M711LS7980Navigation - Vector™ G-ELS-7982026-03-31
M711LA1120Excella®LA-1122024-01-31
M711LA1130Excella®LA-1132024-01-31
M711CI1000Opteryx®CI-100CI-1002018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153046196AVS PLStryker CorporationOVD2015-09-14
07613153046226AVS PLStryker CorporationOVD2015-09-14
07613153046288AVS PLStryker CorporationOVD2015-09-14
07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14
07613153046400AVS TLStryker CorporationOVD2015-09-14
07613153046417AVS TLStryker CorporationOVD2015-09-14
07613153046431AVS TLStryker CorporationOVD2015-09-14
07613153046448AVS TLStryker CorporationOVD2015-09-14
07613153046455AVS TLStryker CorporationOVD2015-09-14
07613153046516AVS TLStryker CorporationOVD2015-09-14
07613153046523AVS TLStryker CorporationOVD2015-09-14
07613153046554AVS TLStryker CorporationOVD2015-09-14
07613153046561AVS TLStryker CorporationOVD2015-09-14
07613153046578AVS TLStryker CorporationOVD2015-09-14
07613153046585AVS TLStryker CorporationOVD2015-09-14
07613153046592AVS TLStryker CorporationOVD2015-09-14
07613153046608AVS TLStryker CorporationOVD2015-09-14
07613153046615AVS TLStryker CorporationOVD2015-09-14
07613153046622AVS TLStryker CorporationOVD2015-09-14
07613153046639AVS TLStryker CorporationOVD2015-09-14
07613153046646AVS TLStryker CorporationOVD2015-09-14
07613153046653AVS TLStryker CorporationOVD2015-09-14
07613153046660AVS TLStryker CorporationOVD2015-09-14
07613153046677AVS TLStryker CorporationOVD2015-09-14
07613153046691AVS TLStryker CorporationOVD2015-09-14