FixxSure
GUDID M711201160
FixxSure Cross Link Hex Driver, SST, Radel
Innovasis, Inc.
Orthopaedic implant driver| Primary Device ID | M711201160 |
| NIH Device Record Key | 71c831be-7103-49b6-9faa-766ec7dafcd5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FixxSure |
| Version Model Number | 20116 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711201160 [Primary] |
FDA Product Code
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
[M711201160]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-09 |
| Device Publish Date | 2024-11-30 |
Devices Manufactured by Innovasis, Inc.
| M711201160 - FixxSure | 2024-12-09FixxSure Cross Link Hex Driver, SST, Radel |
| M711201160 - FixxSure | 2024-12-09 FixxSure Cross Link Hex Driver, SST, Radel |
| M711LS758030 - HAtetracell™-C | 2024-12-09 Trial, 12L x 14W x 9-10H x 12°, SST |
| M711LS758110 - HAtetracell™-C | 2024-12-09 Trial, 13L x 15W x 9-10H x 12°, SST |
| M711LS758120 - HAtetracell™-C | 2024-12-09 Trial, 13L x 15W x 11-12H x 12°, SST |
| M711LS758180 - HAtetracell™-C | 2024-12-09 Trial, 14L x 17W x 11-12H x 12°, SST |
| M711LS758190 - HAtetracell™-C | 2024-12-09 Trial, 15L x 17W x 7-8H x 12°, SST |
| M711LS758200 - HAtetracell™-C | 2024-12-09 Trial, 15L x 17W x 9-10H x 12°, SST |
| M711LS758220 - HAtetracell™-C | 2024-12-09 Trial, 16L x 18W x 7-8H x 12°, SST |
Trademark Results [FixxSure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIXXSURE 77858763 3923949 Live/Registered |
INNOVASIS, INC. 2009-10-27 |
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