CZAR VARIABLE SELF DRILLING SCREW 4.0 64000012

GUDID 00819824024518

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 Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

Primary Device ID	00819824024518
NIH Device Record Key	4cb77523-a8d7-4a3b-91ca-b09b31ea734b
Commercial Distribution Status	In Commercial Distribution
Brand Name	CZAR VARIABLE SELF DRILLING SCREW 4.0
Version Model Number	64000012
Catalog Number	64000012
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	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter
Length	12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819824024518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180772

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body