TxTiHA® TXT12143305
GUDID M711TXT121433051
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
Metallic spinal interbody fusion cage| Primary Device ID | M711TXT121433051 |
| NIH Device Record Key | ce83f1be-11d9-40a9-8ad0-ead415f69a7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TxTiHA® |
| Version Model Number | TXT12143305 |
| Catalog Number | TXT12143305 |
| 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 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
Device Dimensions
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
| Width | 12 Millimeter |
| Height | 14 Millimeter |
| Length | 33 Millimeter |
| Angle | 5 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711TXT121433050 [Primary] |
| HIBCC | M711TXT121433051 [Package] Contains: M711TXT121433050 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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.