TirboLOX-C Cervical IBFD

GUDID M7391810010150

Parallel 0° Cage 15mm x 12mm x 10mm

CAPTIVA SPINE, INC.

Spinal fusion sphere Spinal fusion sphere Spinal fusion sphere Spinal fusion sphere Spinal fusion sphere Spinal fusion sphere Spinal fusion sphere Spinal fusion sphere

• Primary Device ID: M7391810010150
• NIH Device Record Key: d2d06829-f084-4833-bc0c-df2b441ec0a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TirboLOX-C Cervical IBFD
• Version Model Number: 18100-1015
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7391810010150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181229

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[M7391810010150]

Radiation Sterilization

[M7391810010150]

Radiation Sterilization

[M7391810010150]

Radiation Sterilization

[M7391810010150]

Radiation Sterilization

[M7391810010150]

Radiation Sterilization

[M7391810010150]

Radiation Sterilization

[M7391810010150]

Radiation Sterilization

[M7391810010150]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [TirboLOX-C Cervical IBFD]

• M7391810714080: 3D Cage - Lordotic (W)17.5 x (L)14 x (H)8mm
• M7391810714070: 3D Cage - Lordotic (W)17.5 x (L)14 x (H)7mm
• M7391810714060: 3D Cage - Lordotic (W)17.5 x (L)14 x (H)6mm
• M7391810714050: 3D Cage - Lordotic (W)17.5 x (L)14 x (H)5mm
• M7391810712150: 3D Cage - Lordotic (W)15 x (L)12 x (H)12mm
• M7391810711150: 3D Cage - Lordotic (W)15 x (L)12 x (H)11mm
• M7391810710150: 3D Cage - Lordotic (W)15 x (L)12 x (H)10mm
• M7391810709150: 3D Cage - Lordotic (W)15 x (L)12 x (H)9mm
• M7391810708150: 3D Cage - Lordotic (W)15 x (L)12 x (H)8mm
• M7391810707150: 3D Cage - Lordotic (W)15 x (L)12 x (H)7mm
• M7391810706150: 3D Cage - Lordotic (W)15 x (L)12 x (H)6mm
• M7391810705150: 3D Cage - Lordotic (W)15 x (L)12 x (H)5mm
• M7391810510150: 3D Cage - Anatomical (W)15 x (L)12 x (H)10mm
• M7391810509150: 3D Cage - Anatomical (W)15 x (L)12 x (H)9mm
• M7391810508150: 3D Cage - Anatomical (W)15 x (L)12 x (H)8mm
• M7391810507150: 3D Cage - Anatomical (W)15 x (L)12 x (H)7mm
• M7391810506150: 3D Cage - Anatomical (W)15 x (L)12 x (H)6mm
• M7391810505150: 3D Cage - Anatomical (W)15 x (L)12 x (H)5mm
• M7391817512160: Lordotic 7° Cage 16.5mm x 14mm x 12mm
• M7391817511160: Lordotic 7° Cage 16.5mm x 14mm x 11mm
• M7391817510160: Lordotic 7° Cage 16.5mm x 14mm x 10mm
• M7391817509160: Lordotic 7° Cage 16.5mm x 14mm x 9mm
• M7391817508160: Lordotic 7° Cage 16.5mm x 14mm x 8mm
• M7391817507160: Lordotic 7° Cage 16.5mm x 14mm x 7mm
• M7391817506160: Lordotic 7° Cage 16.5mm x 14mm x 6mm
• M7391817505160: Lordotic 7° Cage 16.5mm x 14mm x 5mm
• M7391817012170: Lordotic 7° Cage 17mm x 14mm x 12mm
• M7391817012160: Lordotic 7° Cage 16mm x 14mm x 12mm
• M7391817011170: Lordotic 7° Cage 17mm x 14mm x 11mm
• M7391817011160: Lordotic 7° Cage 16mm x 14mm x 11mm
• M7391817010170: Lordotic 7° Cage 17mm x 14mm x 10mm
• M7391817010160: Lordotic 7° Cage 16mm x 14mm x 10mm
• M7391817009170: Lordotic 7° Cage 17mm x 14mm x 9mm
• M7391817009160: Lordotic 7° Cage 16mm x 14mm x 9mm
• M7391817008170: Lordotic 7° Cage 17mm x 14mm x 8mm
• M7391817008160: Lordotic 7° Cage 16mm x 14mm x 8mm
• M7391817007170: Lordotic 7° Cage 17mm x 14mm x 7mm
• M7391817007160: Lordotic 7° Cage 16mm x 14mm x 7mm
• M7391817006170: Lordotic 7° Cage 17mm x 14mm x 6mm
• M7391817006160: Lordotic 7° Cage 16mm x 14mm x 6mm
• M7391817005170: Lordotic 7° Cage 17mm x 14mm x 5mm
• M7391817005160: Lordotic 7° Cage 16mm x 14mm x 5mm
• M7391815712150: Lordotic 7° Cage 15.5mm x 12mm x 12mm
• M7391815712140: Lordotic 7° Cage 14.5mm x 12mm x 12mm
• M7391815711150: Lordotic 7° Cage 15.5mm x 12mm x 11mm
• M7391815711140: Lordotic 7° Cage 14.5mm x 12mm x 11mm
• M7391815710150: Lordotic 7° Cage 15.5mm x 12mm x 10mm
• M7391815710140: Lordotic 7° Cage 14.5mm x 12mm x 10mm
• M7391815709150: Lordotic 7° Cage 15.5mm x 12mm x 9mm
• M7391815709140: Lordotic 7° Cage 14.5mm x 12mm x 9mm