ANAX™ 5.5 SPINAL SYSTEM
GUDID 08800037503398
U&I CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 08800037503398 |
| NIH Device Record Key | eaae7a58-58a4-4597-b6a5-9183303daca8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANAX™ 5.5 SPINAL SYSTEM |
| Version Model Number | SF5220TSM |
| Company DUNS | 688811082 |
| Company Name | U&I CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800037503398 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173524
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
[08800037503398]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-27 |
| Device Publish Date | 2019-05-17 |
On-Brand Devices [ANAX™ 5.5 SPINAL SYSTEM]
Trademark Results [ANAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANAX 97056657 not registered Live/Pending |
Anaxdent North America LLC 2021-10-01 |
 ANAX 88571862 not registered Live/Pending |
Corbett & Brown Inc. 2019-08-08 |
 ANAX 87276522 5237188 Live/Registered |
Microtech Knives, Inc. 2016-12-21 |
 ANAX 86459418 4772772 Live/Registered |
ANAX Business Technologies, LLC 2014-11-19 |
 ANAX 79024628 3275432 Dead/Cancelled |
DOMAINE GEROVASSILIOU S.A. 2006-05-22 |
 ANAX 77205255 not registered Dead/Abandoned |
Archon Capital Management LLC 2007-06-13 |
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