AxTiHA® AXTi143620
GUDID M711AXTI1436200
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
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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