TirboLOX-L Lumbar IBFD

GUDID M7391931823080

TRIAL Curved LP Lordotic Cage LP 23mm x 8mm

CAPTIVA SPINE, INC.

Spinal implant trial

• Primary Device ID: M7391931823080
• NIH Device Record Key: 7e9db0f3-9327-4cac-abfd-0ab49e6c3824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TirboLOX-L Lumbar IBFD
• Version Model Number: 19318-2308
• Company DUNS: 836975784
• Company Name: CAPTIVA 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

Customer Support Contacts

• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7391931823080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180990

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

[M7391931823080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-03
• Device Publish Date: 2020-10-26

On-Brand Devices [TirboLOX-L Lumbar IBFD]

• M7391910925140: Titanium convex lumbar cage 9.5mm W x 25mm L x 14mm H
• M7391910925130: Titanium convex lumbar cage 9.5mm W x 25mm L x 13mm H
• M7391910925120: Titanium convex lumbar cage 9.5mm W x 25mm L x 12mm H
• M7391910925110: Titanium convex lumbar cage 9.5mm W x 25mm L x 11mm H
• M7391910925100: Titanium convex lumbar cage 9.5mm W x 25mm L x 10mm H
• M7391910925090: Titanium convex lumbar cage 9.5mm W x 25mm L x 9mm H
• M7391910925080: Titanium convex lumbar cage 9.5mm W x 25mm L x 8mm H
• M7391910925070: Titanium convex lumbar cage 9.5mm W x 25mm L x 7mm H
• M7391910922140: Titanium lordotic lumbar cage 9.5mm W x 22mm L x 14mm H
• M7391910922130: Titanium lordotic lumbar cage 9.5mm W x 22mm L x 13mm H
• M7391910922120: Titanium lordotic lumbar cage 9.5mm W x 22mm L x 12mm H
• M7391910922110: Titanium lordotic lumbar cage 9.5mm W x 22mm L x 11mm H
• M7391910922100: Titanium lordotic lumbar cage 9.5mm W x 22mm L x 10mm H
• M7391910922090: Titanium lordotic lumbar cage 9.5mm W x 22mm L x 9mm H
• M7391910922080: Titanium lordotic lumbar cage 9.5mm W x 22mm L x 8mm H
• M7391910922070: Titanium lordotic lumbar cage 9.5mm W x 22mm L x 7mm H
• M7391910630140: Titanium lordotic lumbar cage 9.5mm W x 30mm L x 14mm H
• M7391910630130: Titanium lordotic lumbar cage 9.5mm W x 30mm L x 13mm H
• M7391910630120: Titanium lordotic lumbar cage 9.5mm W x 30mm L x 12mm H
• M7391910630110: Titanium lordotic lumbar cage 9.5mm W x 30mm L x 11mm H
• M7391910630100: Titanium lordotic lumbar cage 9.5mm W x 30mm L x 10mm H
• M7391910630090: Titanium lordotic lumbar cage 9.5mm W x 30mm L x 9mm H
• M7391910630080: Titanium lordotic lumbar cage 9.5mm W x 30mm L x 8mm H
• M7391911125100: 3D Straight Cage 25 x 10mm
• M7391911125090: 3D Straight Cage 25 x 9mm
• M7391911125080: 3D Straight Cage 25 x 8mm
• M7391911136160: 3D Straight Cage 36 x 16mm
• M7391911136150: 3D Straight Cage 36 x 15mm
• M7391911136140: 3D Straight Cage 36 x 14mm
• M7391911136130: 3D Straight Cage 36 x 13mm
• M7391911136120: 3D Straight Cage 36 x 12mm
• M7391911136110: 3D Straight Cage 36 x 11mm
• M7391911136100: 3D Straight Cage 36 x 10mm
• M7391911136090: 3D Straight Cage 36 x 9mm
• M7391911136080: 3D Straight Cage 36 x 8mm
• M7391911134160: 3D Straight Cage 34 x 16mm
• M7391911134150: 3D Straight Cage 34 x 15mm
• M7391911134140: 3D Straight Cage 34 x 14mm
• M7391911134130: 3D Straight Cage 34 x 13mm
• M7391911134120: 3D Straight Cage 34 x 12mm
• M7391911134110: 3D Straight Cage 34 x 11mm
• M7391911134100: 3D Straight Cage 34 x 10mm
• M7391911134090: 3D Straight Cage 34 x 9mm
• M7391911134080: 3D Straight Cage 34 x 8mm
• M7391911132160: 3D Straight Cage 32 x 16mm
• M7391911132150: 3D Straight Cage 32 x 15mm
• M7391911132140: 3D Straight Cage 32 x 14mm
• M7391911132130: 3D Straight Cage 32 x 13mm
• M7391911132120: 3D Straight Cage 32 x 12mm
• M7391911132110: 3D Straight Cage 32 x 11mm