TiBow 60-1136-209X

GUDID 00190837069834

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837069834
• NIH Device Record Key: fe2b2762-3473-49ae-b929-f613d7d9b4a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiBow
• Version Model Number: 60-1136-209X
• Catalog Number: 60-1136-209X
• 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: true
• 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	00190837069834 [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

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

[00190837069834]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

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