CZAR ACP SYSTEM - SCREW INSERTER - SCREW ON 66000005

GUDID 00819824025003

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 ID00819824025003
NIH Device Record Key62db26eb-be9e-478a-8d3d-6f4005e0d0aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCZAR ACP SYSTEM - SCREW INSERTER - SCREW ON
Version Model Number66000005
Catalog Number66000005
Company DUNS080474650
Company NameMET 1 TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com
Phone915-301-0834
Emailyone@met1tech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100819824025003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

[00819824025003]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-14
Device Publish Date2019-03-06

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00819824028950 - 12x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
00819824028967 - 13x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
00819824028974 - 14x22x6° KODIAK PLIF TRIAL2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
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