Velofix™ TLIF Cage
GUDID 08800037508676
U&I CORPORATION
Polymeric spinal interbody fusion cage| Primary Device ID | 08800037508676 |
| NIH Device Record Key | a92b0588-9679-413c-b393-c3b1d84faf8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Velofix™ TLIF Cage |
| Version Model Number | TLA281609T |
| 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 | 08800037508676 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183243
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
[08800037508676]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-12-13 |
On-Brand Devices [Velofix™ TLIF Cage]
Trademark Results [Velofix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VELOFIX 86151986 4788231 Live/Registered |
Velofix Holdings Ltd. 2013-12-24 |
 VELOFIX 85885268 4827448 Live/Registered |
Velofix Holdings Ltd. 2013-03-25 |
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