Cannulated Polyaxial Reduction Screw 4.5 x 40mm

GUDID M739243345400

Cannulated Polyaxial Reduction Screw 4.5 x 40mm

CAPTIVA SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M739243345400
• NIH Device Record Key: 47f89f04-890c-45ce-b5ff-a931e558ed95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Polyaxial Reduction Screw 4.5 x 40mm
• Version Model Number: 2433-4540
• 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	M739243345400 [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

[M739243345400]

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.

• 00850065741000 - EquiLOX Lumbar Expandable Cage - Bone Impactor: 2024-07-24 Bone impactor
• 00850065741017 - EquiLOX Lumbar Expandable Cage - Funnel: 2024-07-24 Funnel
• 00850065741024 - EquiLOX Lumbar Expandable Cage - Cage Holder (w retention rod): 2024-07-24 Cage Holder (w retention rod)
• 00850065741031 - EquiLOX Lumbar Expandable Cage - Square Cage Driver: 2024-07-24 Square Cage Driver
• 00850065741048 - EquiLOX Lumbar Expandable Cage - Hammer connecting shaft: 2024-07-24 Hammer connecting shaft
• 00850065741055 - EquiLOX Lumbar Expandable Cage - Hammer power shaft: 2024-07-24 Hammer power shaft
• 00850065741062 - EquiLOX Lumbar Expandable Cage - Bone Graft Funnel: 2024-07-24 Bone Graft Funnel
• 00850065741079 - EquiLOX Lumbar Expandable Cage - Bone Impactor: 2024-07-24 Bone impactor