Home GUDID B065EX070 ExoToe
Primary DI B065EX070
Brand ExoToe
Company EXOTOE, LLC
Model EX070
Device description ExoToe Staple 7.0
Published 2020-06-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name JDR Staple, Fixation, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JDR Staple, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B065EX070 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone staple, non-adjustable, sterile A sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.
Regulatory Flags# DUNS number 081016089 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810111227223 SpeedMTP Select Treace Medical Concepts, Inc. JDR 2026-05-13 00810111227247 SpeedMTP Select Treace Medical Concepts, Inc. JDR 2026-05-13 00810111227254 SpeedMTP Select Treace Medical Concepts, Inc. JDR 2026-05-13 00810111224062 TMC SpeedMTP Treace Medical Concepts, Inc. JDR 2026-03-30 00810111224833 TMC Nanoplasty System Treace Medical Concepts, Inc. JDR 2025-10-10 00811714036458 Thunderbolt RESPONSIVE ORTHOPEDICS LLC JDR 2025-05-14 00811714036465 Thunderbolt RESPONSIVE ORTHOPEDICS LLC JDR 2025-05-14 10886705001033 LUPINE DEPUY MITEK, LLC JDR 2025-03-04 10886705001040 LUPINE DEPUY MITEK, LLC JDR 2025-03-04 00810111223683 SpeedPlate - SpeedAkin Treace Medical Concepts, Inc. JDR 2025-01-27 00810111223485 TMC SpeedMTP Treace Medical Concepts, Inc. JDR 2024-11-18 07630037889397 APTUS Medartis AG JDR 2023-03-03 10888867042633 Arthrex® ARTHREX, INC. JDR 2021-12-03 10888867042640 Arthrex® ARTHREX, INC. JDR 2021-12-03 10888867042671 Arthrex® ARTHREX, INC. JDR 2021-12-03 10888867042688 Arthrex® ARTHREX, INC. JDR 2021-12-03 10888867042695 Arthrex® ARTHREX, INC. JDR 2021-12-03 00811714035345 Thunderbolt Suture Assembly RESPONSIVE ORTHOPEDICS LLC JDR 2021-04-29 00811714035352 Thunderbolt Plate RESPONSIVE ORTHOPEDICS LLC JDR 2021-04-29 07630971238039 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238046 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238053 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238060 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238077 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238084 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238091 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238107 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238114 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 07630971238121 MectaFix CL Fixation Button with Continuous Loop Medacta International SA JDR 2020-06-12 00815432025138 MotoBAND CROSSROADS EXTREMITY SYSTEMS JDR 2018-08-06