Polyaxial Screw 4.5 x 55mm

GUDID M739241245550

Polyaxial Screw 4.5 x 55mm

CAPTIVA SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M739241245550
• NIH Device Record Key: 7e3a139b-33a4-4d43-b719-7ef70b9cb639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polyaxial Screw 4.5 x 55mm
• Version Model Number: 2412-4555
• 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	M739241245550 [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

[M739241245550]

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

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