Home GUDID 00810005667159 Trigon
Primary DI 00810005667159
Brand Trigon
Company NVision Biomedical Technologies, Inc.
Model LDP-2405-0204
Device description 5mm (2° Sagittal 4° Transverse) PEEK Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
Published 2024-02-22
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 HRS Plate, Fixation, Bone HWC Screw, Fixation, Bone PLF Bone Wedge
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2 HWC Screw, Fixation, Bone Orthopedic 2 PLF Bone Wedge Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810005667159 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 00810005667159 00810005667159 810005667159 0810005667159
GMDN Terms# Term, Definition table Term Definition Polymeric osteotomy fusion cage, non-customized A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of synthetic polymer [e.g., polyetheretherketone (PEEK)].
Device Sizes# Type, Value, Unit table Type Value Unit Height 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 047486041 Device count 1 DM exempt true 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 00196449002511 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002528 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002535 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002542 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002559 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002566 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002573 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002580 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002597 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002603 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002610 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002627 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002634 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002641 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002658 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002665 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002672 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002689 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002696 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002702 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002719 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002726 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002733 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002740 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002757 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002764 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002771 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002788 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002795 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08 00196449002801 LEOS Cannulated Screw System Tyber Medical, LLC HWC 2023-12-08