AxTiHA® BTA-145
GUDID M711BTA1450
Polypropylene, Radel, SST
Innovasis, Inc.
Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable| Primary Device ID | M711BTA1450 |
| NIH Device Record Key | b0fd0706-6a88-47e5-8779-716a815f8f3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AxTiHA® |
| Version Model Number | BTA-145 |
| Catalog Number | BTA-145 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711BTA1450 [Primary] |
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 | true |
| Device Is Sterile | false |
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
[M711BTA1450]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-08 |
| Device Publish Date | 2021-08-31 |
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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