Home GUDID M7401610041 OptiMesh Navigation Instruments
Primary DI M7401610041
Brand OptiMesh Navigation Instruments
Company SPINEOLOGY INC.
Model 16-13-08
Catalog number 161-0041
Device description Navigation Portal Head
Published 2025-12-17
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
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 M7401610041 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, single-use 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, prosthesis, or prosthesis component; 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 single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 033014361 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M7404300035 CAPTURE Facet Screw Set System 70-02-008-1 430-0035 2026-05-29 M7403030028 Discectomy Set 15-01-45-1 303-0028 2026-05-28 M7403030029 Discectomy Set 15-01-45-2 303-0029 2026-05-28 M7403030030 Discectomy Set 15-01-45-3 303-0030 2026-05-28 M7403030031 Discectomy Set 15-01-45-4 303-0031 2026-05-28 M7403030032 Discectomy Set 15-01-45-5 303-0032 2026-05-28 M7403030033 Discectomy Set 15-01-45-6 303-0033 2026-05-28 M7403030034 Discectomy Set 15-01-45-7 303-0034 2026-05-28 M7403030035 Discectomy Set 15-01-45-8 303-0035 2026-05-28 M7403030036 Discectomy Set 15-01-45-9 303-0036 2026-05-28 M7403030059 Discectomy Set 15-01-45-10 303-0059 2026-05-28 M7403030060 Discectomy Set 15-01-45-11 303-0060 2026-05-28 M7401001373 MIS TLIF System 102-86-01 100-1373 2026-05-21 M7401001371 OptiLIF Endo, Direct Visualization System 102-84-01 100-1371 2026-04-06 M7406410015 Fortress Pedicular Fixation 64-02-01 641-0015 2024-01-10 M7406410071 Fortress Pedicular Fixation 55-03-20 641-0071 2024-01-10 M7408610084 Duo Expandable Interbody Fusion System 86-11-51 861-0084 2023-12-28 M7407408599 Fortress Pedicale Screw 10-10-57-45 740-8599 2015-09-17 M7407404525 Fortress Pedicale Screw 10-10-57-1 740-4525 2015-09-17 M7407404530 Fortress Pedicale Screw 10-10-57-2 740-4530 2015-09-17
Other Devices Sharing Product Codes# 
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