Home GUDID 00810135962216 Trigon
Primary DI 00810135962216
Brand Trigon
Company NVision Biomedical Technologies, Inc.
Model LMP-1414-0600
Device description 6mm Wedge Parallel PEEK Small Single Joint Lesser Metatarsal 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 • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular 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 2025-05-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
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 00810135962216 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 00810135962216 00810135962216 810135962216 0810135962216
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)].
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 00885556819845 Uni-CP Compression Plate Smith & Nephew, Inc. HRS 2023-11-07 00885556819852 Uni-CP Compression Plate Smith & Nephew, Inc. HRS 2023-11-07 00885556819869 Uni-CP Compression Plate Smith & Nephew, Inc. HRS 2023-11-07 00885556819876 Uni-CP Compression Plate Smith & Nephew, Inc. HRS 2023-11-07 00885556819883 Uni-CP Compression Plate Smith & Nephew, Inc. HRS 2023-11-07 00885556819890 Uni-CP Compression Plate Smith & Nephew, Inc. HRS 2023-11-07 00885556819906 Uni-CP Compression Plate Smith & Nephew, Inc. HRS 2023-11-07 00885556819722 Total Wrist Fusion Smith & Nephew, Inc. HRS 2023-10-26 00885556819746 Total Wrist Fusion Smith & Nephew, Inc. HRS 2023-10-26 00885556819760 Total Wrist Fusion Smith & Nephew, Inc. HRS 2023-10-26 00885556819807 UNI-CP Compression Plate Smith & Nephew, Inc. HRS 2023-10-26 00885556819814 UNI-CP Compression Plate Smith & Nephew, Inc. HRS 2023-10-26 00885556819821 UNI-CP Compression Plate Smith & Nephew, Inc. HRS 2023-10-26 00885556819838 UNI-CP Compression Plate Smith & Nephew, Inc. HRS 2023-10-26 00885556819623 Total Wrist Fusion Smith & Nephew, Inc. HRS 2023-10-25 00885556819647 SURFIXTotal Wrist Fusion Smith & Nephew, Inc. HRS 2023-10-25 00885556819661 Total Wrist Fusion Smith & Nephew, Inc. HRS 2023-10-25 00885556819685 Total Wrist Fusion Smith & Nephew, Inc. HRS 2023-10-25 00885556819708 Total Wrist Fusion Smith & Nephew, Inc. HRS 2023-10-25 00885556838303 Total Foot System 2 Smith & Nephew, Inc. HWC 2023-04-25 00885556838303 Total Foot System 2 Smith & Nephew, Inc. HRS 2023-04-25 00885556838327 Total Foot System 2 Smith & Nephew, Inc. HWC 2023-04-18 00885556838327 Total Foot System 2 Smith & Nephew, Inc. HRS 2023-04-18 00885556824764 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824771 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824788 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824795 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824818 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556824825 DigiFuse Cannulated Intramedullary Fusion Smith & Nephew, Inc. HWC 2023-02-10 00885556835043 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22
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