Home GUDID 00819824024839 CZAR FIXED SELF TAPPING SCREW 4.0
Primary DI 00819824024839
Brand CZAR FIXED SELF TAPPING SCREW 4.0
Company MET 1 TECHNOLOGIES, LLC
Model 64010116
Catalog number 64010116
Device description 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.
Published 2019-03-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00819824024839 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00819824024839 00819824024839 819824024839 0819824024839
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
Device Sizes# Type, Value, Unit table Type Value Unit Length 16 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080474650 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00819824024129 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010012 60010012 2019-03-06 00819824024136 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010014 60010014 2019-03-06 00819824024143 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010016 60010016 2019-03-06 00819824024150 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010018 60010018 2019-03-06 00819824024167 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010020 60010020 2019-03-06 00819824024174 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010022 60010022 2019-03-06 00819824024181 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010024 60010024 2019-03-06 00819824024198 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020024 60020024 2019-03-06 00819824024204 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020026 60020026 2019-03-06 00819824024211 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020028 60020028 2019-03-06 00819824024228 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020030 60020030 2019-03-06 00819824024235 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020032 60020032 2019-03-06 00819824024242 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020034 60020034 2019-03-06 00819824024259 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020037 60020037 2019-03-06 00819824024266 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020040 60020040 2019-03-06 00819824024273 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020043 60020043 2019-03-06 00819824024280 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020046 60020046 2019-03-06 00819824024297 CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL 60030039 60030039 2019-03-06 00819824024303 CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL 60030042 60030042 2019-03-06 00819824024310 CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL 60030045 60030045 2019-03-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810017915125 SABER-XA, Screw Ø5.0 x 22.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915149 SABER-XA, Screw Ø5.0 x 32.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915156 SABER-XA, Screw Ø5.5 x 22.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915163 SABER-XA, Screw Ø5.5 x 27.5 ELEVATION SPINE, INC. KWQ 2026-09-22 00810017915170 SABER-XA, Screw Ø5.5 x 32.5 ELEVATION SPINE, INC. KWQ 2026-09-22 10888857598164 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598171 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598188 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598195 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598201 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598218 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598225 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598232 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 10888857598249 Xia® 3 System - Serrato® VB Spine LLC KWQ 2026-07-24 00810056993146 corra Carlsmed, Inc. KWQ 2026-01-30 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWQ 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWQ 2015-08-05 04546540147257 XIA II Stryker Corporation KWQ 2014-12-08 04546540147769 XIA II Stryker Corporation KWQ 2014-12-08 04546540147806 XIA II Stryker Corporation KWQ 2014-12-08 04546540147905 XIA II Stryker Corporation KWQ 2014-12-08 04546540147912 XIA I Stryker Corporation KWQ 2014-12-08 04546540147929 XIA I Stryker Corporation KWQ 2014-12-08 04546540147936 XIA I Stryker Corporation KWQ 2014-12-08 04546540147974 XIA I Stryker Corporation KWQ 2014-12-08 04546540147981 XIA I Stryker Corporation KWQ 2014-12-08 04546540147998 XIA I Stryker Corporation KWQ 2014-12-08 04546540148001 XIA II Stryker Corporation KWQ 2014-12-08 04546540148018 XIA II Stryker Corporation KWQ 2014-12-08 04546540148025 XIA II Stryker Corporation KWQ 2014-12-08