Home GUDID M9461090040 Tibia Tracking Array
Primary DI M9461090040
Brand Tibia Tracking Array
Company THINK SURGICAL, INC.
Model 109004
Catalog number 109004
Published 2023-08-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OLO Orthopedic stereotaxic instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLO Orthopedic Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M9461090040 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007211430 Device count 1 DM exempt true Serial number true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M9461034491 CT Motion Rod, 54 inch 103449 103449 2023-08-28 M9461037251 CT Motion Rod, 42 inch 103725 103725 2023-08-28 M9461087570 TMINI™ Navigation Console 108757 108757 2023-08-28 M9461005730 Tsolution One Surgical System 100573 2016-09-24 M9461027090 Tsolution One Surgical System 102709 2016-09-24 M9461029400 Tsolution One Surgical System 102940 2016-09-24 M9461032050 Tsolution One Surgical System 103205 2016-09-24 M9461033840 Tsolution One Surgical System 103384 2016-09-24 M9461034140 Tsolution One Surgical System 103414 2016-09-24 M9461034260 Tsolution One Surgical System 103426 2016-09-24 M9461035930 Tsolution One Surgical System 103593 2016-09-24 M9461037250 Tsolution One Surgical System 103725 2016-09-24 M9461049480 Tsolution One Surgical System 104948 2016-09-24 M9461056530 Tsolution One Surgical System 105653 2016-09-24 M9461057160 Tsolution One Surgical System 105716 2016-09-24 M9461057170 Tsolution One Surgical System 105717 2016-09-24 M9461059340 Tsolution One Surgical System 105934 2016-09-24 M9461062190 Tsolution One Surgical System 106219 2016-09-24 M946106298030 Tsolution One Surgical System 106298-03 2016-09-24 M946106298040 Tsolution One Surgical System 106298-04 2016-09-24
Other Devices Sharing Product Codes# 
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