Home GUDID G712PN00774100
HYALEX Slalom™ MTP Hemiarthroplasty System
Primary DI G712PN00774100
Brand HYALEX Slalom™ MTP Hemiarthroplasty System
Company Hyalex Orthopaedics, Inc.
Model PN-00774-10
Catalog number PN-00774-10
Device description HYALEX Slalom™ MTP Hemiarthroplasty Drill Guide, 10mm
Published 2026-06-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name KWD Prosthesis, Toe, Hemi-, Phalangeal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G712PN00774100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080784794 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G712PN00720100 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00720-10 PN-00720-10 2026-06-05 G712PN00720120 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00720-12 PN-00720-12 2026-06-05 G712PN00734100 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00734-10 PN-00734-10 2026-06-05 G712PN00734120 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00734-12 PN-00734-12 2026-06-05 G712PN00763100 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00763-10 PN-00763-10 2026-06-05 G712PN00763120 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00763-12 PN-00763-12 2026-06-05 G712PN007641 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00764 PN-00764 2026-06-05 G712PN00765100 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00765-10 PN-00765-10 2026-06-05 G712PN00765120 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00765-12 PN-00765-12 2026-06-05 G712PN00774120 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00774-12 PN-00774-12 2026-06-05 G712PN00777100 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00777-10 PN-00777-10 2026-06-05 G712PN00777120 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00777-12 PN-00777-12 2026-06-05 G712PN007840 HYALEX Slalom™ MTP Hemiarthroplasty System PN-00784 PN-00784 2026-06-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G712PN00720100 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00720120 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00734100 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00734120 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00763100 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00763120 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN007641 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00765100 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00765120 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00774120 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00777100 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN00777120 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 G712PN007840 HYALEX Slalom™ MTP Hemiarthroplasty System Hyalex Orthopaedics, Inc. KWD 2026-06-05 00810005668095 Trigon NVISION BIOMEDICAL TECHNOLOGIES, INC. KWD 2026-04-24 00810005668101 Trigon NVISION BIOMEDICAL TECHNOLOGIES, INC. KWD 2026-04-24 00810005668118 Trigon NVISION BIOMEDICAL TECHNOLOGIES, INC. KWD 2026-04-24 00810005668187 Trigon NVISION BIOMEDICAL TECHNOLOGIES, INC. KWD 2026-04-24 00810135963565 Trigon NVISION BIOMEDICAL TECHNOLOGIES, INC. KWD 2026-04-24 00810135963572 Trigon NVISION BIOMEDICAL TECHNOLOGIES, INC. KWD 2026-04-24 00850044114962 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635037 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635198 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635204 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635211 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635228 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635235 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635242 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635259 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635266 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11 00850061635273 Accu-Joint Accufix Surgical, Inc. KWD 2024-11-11