Home GUDID B562XKEFC0422STUS0 EpiFIX
Primary DI B562XKEFC0422STUS0
Brand EpiFIX
Company Wishbone Medical, Inc.
Model XK-EFC0422ST-US
Catalog number XK-EFC0422ST
Device description Express Kit, Curved 4-Hole x 22mm EpiFIX Plate, Instruments and Solid Screws, Ti
Published 2021-09-15
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B562XKEFC0422STUS0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Growth-correction orthopaedic fixation plate kit A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.
Regulatory Flags# DUNS number 062355158 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B56251300MDG000G10 WishBone Plate & Screw System 51-300-MDG000G-1 51-300-MDG000G-1 2024-01-01 B562TCX27008US0 2.7mm x 8mm Ti Cortical Screw TCX27008-US TCX27008 2019-11-25 B562TCX27010US0 2.7mm x 10mm Ti Cortical Screw TCX27010-US TCX27010 2019-11-25 B562TCX27012US0 2.7mm x 12mm Ti Cortical Screw TCX27012-US TCX27012 2019-11-25 B562TCX27014US0 2.7mm x 14mm Ti Cortical Screw TCX27014-US TCX27014 2019-11-25 B562TCX27016US0 2.7mm x 16mm Ti Cortical Screw TCX27016-US TCX27016 2019-11-25 B562TCX27018US0 2.7mm x 18mm Ti Cortical Screw TCX27018-US TCX27018 2019-11-25 B562TCX27020US0 2.7mm x 20mm Ti Cortical Screw TCX27020-US TCX27020 2019-11-25 B562TCX27022US0 2.7mm x 22mm Ti Cortical Screw TCX27022-US TCX27022 2019-11-25 B562TCX27024US0 2.7mm x 24mm Ti Cortical Screw TCX27024-US TCX27024 2019-11-25 B562TCX27026US0 2.7mm x 26mm Ti Cortical Screw TCX27026-US TCX27026 2019-11-25 B562TCX27028US0 2.7mm x 28mm Ti Cortical Screw TCX27028-US TCX27028 2019-11-25 B562TCX27030US0 2.7mm x 30mm Ti Cortical Screw TCX27030-US TCX27030 2019-11-25 B562TCX27032US0 2.7mm x 32mm Ti Cortical Screw TCX27032-US TCX27032 2019-11-25 B562TCX27034US0 2.7mm x 34mm Ti Cortical Screw TCX27034-US TCX27034 2019-11-25 B562TCX27036US0 2.7mm x 36mm Ti Cortical Screw TCX27036-US TCX27036 2019-11-25 B562TCX27038US0 2.7mm x 38mm Ti Cortical Screw TCX27038-US TCX27038 2019-11-25 B562TCX27040US0 2.7mm x 40mm Ti Cortical Screw TCX27040-US TCX27040 2019-11-25 B562TCX27045US0 2.7mm x 45mm Ti Cortical Screw TCX27045-US TCX27045 2019-11-25 B562TCX27050US0 2.7mm x 50mm Ti Cortical Screw TCX27050-US TCX27050 2019-11-25
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