TxTiHA® TXT10092812

GUDID M711TXT100928121

Ti 6Al 4V (ELI); Hydroxyapatite

Innovasis, Inc.

Metallic spinal interbody fusion cage

Primary Device ID	M711TXT100928121
NIH Device Record Key	0f765922-da99-4cd2-8635-eeeca9dc12ef
Commercial Distribution Status	In Commercial Distribution
Brand Name	TxTiHA®
Version Model Number	TXT10092812
Catalog Number	TXT10092812
Company DUNS	156567492
Company Name	Innovasis, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com
Phone	801-261-2236
Email	info@innovasis.com

Device Dimensions

Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree
Width	10 Millimeter
Height	9 Millimeter
Length	28 Millimeter
Angle	12.5 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711TXT100928120 [Primary]
HIBCC	M711TXT100928121 [Package] Contains: M711TXT100928120 Package: Carton [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K201614

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-10-08
Device Publish Date	2021-09-30

On-Brand Devices [TxTiHA®]

M711TXT121633121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121633101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121633051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121533121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121533101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121533051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121433121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121433101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121433051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121333121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121333101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121333051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121233121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121233101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121233051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121133121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121133101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121133051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121033121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121033101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT121033051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT120933121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT120933101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT120933051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT120833051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101628121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101628101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101628051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101528121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101528101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101528051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101428121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101428101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101428051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101328121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101328101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101328051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101228121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101228101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101228051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101128121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101128101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101128051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101028121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101028101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT101028051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT100928121	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT100928101	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT100928051	Ti 6Al 4V (ELI); Hydroxyapatite
M711TXT100828101	Ti 6Al 4V (ELI); Hydroxyapatite

Trademark Results [TxTiHA]

Mark Image Registration \| Serial	Company Trademark Application Date
TXTIHA 88864510 not registered Live/Pending	Innovasis, Inc. 2020-04-08