CZAR VARIABLE SELF DRILLING SCREW 4.0 64000016

GUDID 00819824024532

THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATION OF THE CERVICAL SPINE. THE SYSTEM INCLUDES SCREWS, PLATES, AND A SET OF INSTRUMENTS TO INSERT THE IMPLANTS. PLATES ARE AVAILABLE IN A VARIETY OF LENGTHS TO ACCOMODATE FUSION PROCEDURES FROM ONE TO FOUR LEVELS OF THE CERVICAL SPINE. FIXATION IS ACHIEVED BY INSERTING THE SCREWS THROUGH THE OPENINGS IN THE PLATE INTO VERTEBRAL BODIES OF THE CERVICAL SPINE. THE PLATES ARE MANUFACTURED FROM TITANIUM 6 A1-4V ELI PER ASTM F136 AND INVIBIO PEEK-OPTIMA LT1 PER ASTM F2026.

MET 1 TECHNOLOGIES, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00819824024532
• NIH Device Record Key: defe6bce-c9f2-4cf1-896a-658d8839aa5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CZAR VARIABLE SELF DRILLING SCREW 4.0
• Version Model Number: 64000016
• Catalog Number: 64000016
• Company DUNS: 080474650
• Company Name: MET 1 TECHNOLOGIES, LLC
• 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: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com
• Phone: 915-301-0834
• Email: yone@met1tech.com

Device Dimensions

• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819824024532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180772

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

[00819824024532]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-14
• Device Publish Date: 2019-03-06

On-Brand Devices [CZAR VARIABLE SELF DRILLING SCREW 4.0]

• 00819824024549: THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATIO
• 00819824024532: THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATIO
• 00819824024525: THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATIO
• 00819824024518: THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATIO
• 00819824024501: THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATIO