TowerLOX EXT Cannulated Polyaxial EXT Screw 4.5 x 35mm

GUDID M7391613545350

TowerLOX EXT Cannulated Polyaxial EXT Screw 4.5 x 35mm

CAPTIVA SPINE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M7391613545350
• NIH Device Record Key: 6b73f9cb-48fd-466c-91bc-da0338f843cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TowerLOX EXT Cannulated Polyaxial EXT Screw 4.5 x 35mm
• Version Model Number: 16135-4535
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7391613545350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193270

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[M7391613545350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-09
• Device Publish Date: 2020-04-01

Devices Manufactured by CAPTIVA SPINE, INC.

• 00850065741567 - Trial 7mm: 2025-08-27 7mm Trial
• 00850065741574 - Trial 8mm: 2025-08-27 8mm Trial
• 00850065741581 - Trial 9mm: 2025-08-27 9mm Trial
• 00850065741598 - Trial 10mm: 2025-08-27 10mm Trial
• 00850065741604 - Trial 11mm: 2025-08-27 11mm Trial
• 00850065741611 - Trial 12mm: 2025-08-27 12mm Trial
• 00850065741628 - Distraction Paddle - 7mm: 2025-08-27 Distraction Paddle - 7mm
• 00850065741635 - Distraction Paddle - 8mm: 2025-08-27 Distraction Paddle - 8mm