TiBow 129-590
GUDID 00190837069605
Expandable TLIF Installer
Life Spine, Inc.
Metallic spinal fusion cage, non-sterile| Primary Device ID | 00190837069605 |
| NIH Device Record Key | 20dcc30e-c9aa-4f56-946d-552214357b1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiBow |
| Version Model Number | 129-590 |
| Catalog Number | 129-590 |
| Company DUNS | 183641617 |
| Company Name | Life Spine, 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190837069605 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170919
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
[00190837069605]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-14 |
| Device Publish Date | 2019-11-06 |
On-Brand Devices [TiBow]
| 00190837069643 | TiBOW 36mm Caddy |
| 00190837069636 | TiBOW 28mm Caddy |
| 00190837069629 | Expandable Trial, 36mm |
| 00190837069612 | Expandable Trial, 28mm |
| 00190837069605 | Expandable TLIF Installer |
| 00190837069599 | 5mm Hex Driver |
| 00190837069582 | TiBOW Trial, 36mm x 12mm, 12 Degree |
| 00190837069568 | TiBOW Trial, 36mm x 10mm, 12 Degree |
| 00190837069551 | TiBOW Trial, 36mm x 9mm, 12 Degree |
| 00190837069544 | TiBOW Trial, 36mm x 8mm, 12 Degree |
| 00190837069537 | TiBOW Trial, 36mm x 12mm, 7 Degree |
| 00190837069520 | TiBOW Trial, 36mm x 11mm, 7 Degree |
| 00190837069513 | TiBOW Trial, 36mm x 10mm, 7 Degree |
| 00190837069506 | TiBOW Trial, 36mm x 9mm, 7 Degree |
| 00190837069490 | TiBOW Trial, 36mm x 8mm, 7 Degree |
| 00190837069483 | TiBOW Trial, 28mm x 12mm, 12 Degree |
| 00190837069476 | TiBOW Trial, 28mm x 11mm, 12 Degree |
| 00190837069469 | TiBOW Trial, 28mm x 10mm, 12 Degree |
| 00190837069452 | TiBOW Trial, 28mm x 9mm, 12 Degree |
| 00190837069445 | TiBOW Trial, 28mm x 8mm, 12 Degree |
| 00190837069438 | TiBOW Trial, 28mm x 12mm, 7 Degree |
| 00190837069414 | TiBOW Trial, 28mm x 10mm, 7 Degree |
| 00190837069391 | TiBOW Trial, 28mm x 8mm, 7 Degree |
| 00190837069865 | 60-1136-212X |
| 00190837069858 | 60-1136-211X |
| 00190837069841 | 60-1136-210X |
| 00190837069834 | 60-1136-209X |
| 00190837069827 | 60-1136-208X |
| 00190837069810 | 60-1136-112X |
| 00190837069803 | 60-1136-111X |
| 00190837069797 | 60-1136-110X |
| 00190837069780 | 60-1136-109X |
| 00190837069773 | 60-1136-108X |
| 00190837069766 | 60-1128-212X |
| 00190837069759 | 60-1128-211X |
| 00190837069742 | 60-1128-210X |
| 00190837069735 | 60-1128-209X |
| 00190837069728 | 60-1128-208X |
| 00190837069711 | 60-1128-112X |
| 00190837069704 | 60-1128-111X |
| 00190837069698 | 60-1128-110X |
| 00190837069681 | 60-1128-109X |
| 00190837069674 | 60-1128-108X |
| 00190837069667 | Bone Plunger |
| 00190837069650 | Bone Funnel |
| 00190837069575 | TiBOW Trial, 36mm x 11mm, 12 Degree |
| 00190837069421 | TiBOW Trial, 28mm x 11mm, 7 Degree |
| 00190837069407 | TiBOW Trial, 28mm x 9mm, 7 Degree |
| 00190837069384 | TiBow Trial, 36mm x 8mm, 12 Degree |
| 00190837069377 | TiBow Trial, 28mm x 9mm, 12 Degree |
Trademark Results [TiBow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIBOW 87293820 5460012 Live/Registered |
Life Spine, Inc. 2017-01-09 |
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