Home GUDID 00810005666992 Trigon
Primary DI 00810005666992
Brand Trigon
Company NVision Biomedical Technologies, Inc.
Model LDP-2408-0408
Device description 8mm (4° Sagittal 8° 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 00810005666992 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 00810005666992 00810005666992 810005666992 0810005666992
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 00885556836187 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836163 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836170 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836194 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836200 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836217 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836224 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836248 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836255 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836262 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835999 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836002 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836019 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836026 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836033 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836040 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836057 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836064 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836071 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836088 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836095 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836118 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836125 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836132 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836149 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836156 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556838785 Total Foot System 2 Smith & Nephew, Inc. HRS 2022-12-21 00885556838785 Total Foot System 2 Smith & Nephew, Inc. HWC 2022-12-21 00888867007475 Arthrex® ARTHREX, INC. HRS 2017-02-15 00888867007499 Arthrex® ARTHREX, INC. HRS 2017-02-15
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