FDA.reportPublic FDA data

TxTiHA®

Primary DI
M711TXT101028051
Brand
TxTiHA®
Company
Innovasis, Inc.
Model
TXT10102805
Catalog number
TXT10102805
Device description
Ti 6Al 4V (ELI); Hydroxyapatite
Published
2021-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201614000TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020-07-15MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711TXT101028051PackageHIBCC1In Commercial Distribution
M711TXT101028050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle5degree
Height10Millimeter
Length28Millimeter
Width10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
156567492
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M71165161812081HAtetracell™-C65-161812082024-10-31
M71165161812121HAtetracell™-C65-161812122024-09-30
M71165161905081HAtetracell™-C65-161905082024-09-30
M71165161906121HAtetracell™-C65-161906122024-09-30
M71165161907121HAtetracell™-C65-161907122024-09-30
M71165161908081HAtetracell™-C65-161908082024-09-30
M71165161908121HAtetracell™-C65-161908122024-09-30
M71165161909081HAtetracell™-C65-161909082024-09-30
M71165161909121HAtetracell™-C65-161909122024-09-30
M71165161910081HAtetracell™-C65-161910082024-09-30
M71165161910121HAtetracell™-C65-161910122024-09-30
M71165161911081HAtetracell™-C65-161911082024-09-30
M71165161911121HAtetracell™-C65-161911122024-09-30
M71165161912081HAtetracell™-C65-161912082024-09-30
M71165161912121HAtetracell™-C65-161912122024-09-30
M71165161806121HAtetracell™-C65-161806122024-08-31
M71165161807081HAtetracell™-C65-161807082024-08-31
M71165161807121HAtetracell™-C65-161807122024-08-31
M71165161808081HAtetracell™-C65-161808082024-08-31
M71165161808121HAtetracell™-C65-161808122024-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
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00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102364Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102388Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102401Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102418Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102425Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22