Home GUDID 00197157082017 ZAVATION SCREW
Primary DI 00197157082017
Brand ZAVATION SCREW
Company Zavation LLC
Model 35045-26
Device description 3500 SERIES POLYAXIAL SCREW - 4.5MM X 26MM
Published 2026-06-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KWP Appliance, Fixation, Spinal Interlaminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00197157082017 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 00197157082017 00197157082017 197157082017 0197157082017
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw (non-sliding) A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 069472800 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00193982239862 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982239886 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982239909 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982239923 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982239947 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982239961 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982240240 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982240363 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982240622 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982450151 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982450168 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982450175 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982450182 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982450199 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521134 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521141 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521158 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521165 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521172 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521189 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521196 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521202 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521219 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521226 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521233 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521240 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521257 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521264 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982521271 QUARTEX GLOBUS MEDICAL, INC. KWP 2026-08-14 00193982669638 CREO GLOBUS MEDICAL, INC. KWP 2026-08-14
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