AxTiHA® AXTi143620
GUDID M711AXTI1436200
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage| Primary Device ID | M711AXTI1436200 |
| NIH Device Record Key | 56347a24-5e93-4827-ac41-137696d3c7c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AxTiHA® |
| Version Model Number | AXTi143620 |
| Catalog Number | AXTi143620 |
| 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 | |
| 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
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
| Height | 14 Millimeter |
| Width | 36 Millimeter |
| Angle | 20 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711AXTI1436200 [Primary] |
| HIBCC | M711AXTI1436201 [Package] Package: Carton [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182139
FDA Product Code
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-08-31 |
| Device Publish Date | 2020-10-05 |
On-Brand Devices [AxTiHA®]
| M711AXTI1436200 | Ti 6Al 4V (ELI); Hydroxyapatite |
| M711BTA1450 | Polypropylene, Radel, SST |
Trademark Results [AxTiHA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AXTIHA 88864494 not registered Live/Pending |
Innovasis, Inc. 2020-04-08 |
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