TowerLOX EXT Cannulated Polyaxial EXT Screw 8.0 x 35mm

GUDID M7391613580350

TowerLOX EXT Cannulated Polyaxial EXT Screw 8.0 x 35mm

CAPTIVA SPINE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M7391613580350
• NIH Device Record Key: cbbe0265-1c80-436a-83f2-47f3e0e72070
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TowerLOX EXT Cannulated Polyaxial EXT Screw 8.0 x 35mm
• Version Model Number: 16135-8035
• 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: 5612779480
• Email: info@captivaspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7391613580350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180475

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[M7391613580350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-29

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