Home GUDID B562XKEFC0212STUS0 EpiFIX
Primary DI B562XKEFC0212STUS0
Brand EpiFIX
Company Wishbone Medical, Inc.
Model XK-EFC0212ST-US
Catalog number XK-EFC0212ST
Device description Express Kit, Curved 2-Hole X 12mm 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 B562XKEFC0212STUS0 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B562PKEFC0416S080 WishFIX Wishbone Medical, Inc. OBT 2023-03-16 B562XKEFC0414S080 WishFIX Wishbone Medical, Inc. OBT 2021-12-21 B562XKEFC0414SS080 WishFIX Wishbone Medical, Inc. OBT 2021-12-21 B562XKEFC0414ST080 WishFIX Wishbone Medical, Inc. OBT 2021-12-21 B562XKEFC0414T080 WishFIX Wishbone Medical, Inc. OBT 2021-12-21 B562XKEFC0414T08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-21 B562PKEFC0414S080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0414S08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0414SS080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0414SS08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0414ST080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0414ST08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0414T080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0414T08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0416S08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0416SS080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0416SS08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0416ST080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0416ST08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0416T080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0416T08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0422S080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0422S08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0422SS080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0422SS08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0422ST080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0422ST08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0422T080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0422T08US0 WishFIX Wishbone Medical, Inc. OBT 2021-12-20 B562PKEFC0426S080 WishFIX Wishbone Medical, Inc. OBT 2021-12-20