Home GUDID M7405300040 Threshold Pedicular Fixation System
Primary DI M7405300040
Brand Threshold Pedicular Fixation System
Company SPINEOLOGY INC.
Model 53-02-22
Catalog number 530-0040
Device description Internal Rod Reducer
Published 2024-01-05
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M7405300040 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic rod reducer A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 033014361 Device count 1 Premarket exempt true 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 M7403030001 Discectomy Set 10-01-138 303-0001 2026-07-08 M7403030002 Discectomy Set 10-01-139 303-0002 2026-07-08 M7403030069 Discectomy Set 15-01-58 303-0069 2026-07-08 M7403030070 Discectomy Set 15-01-59 303-0070 2026-07-08 M7403030071 Discectomy Set 15-01-60 303-0071 2026-07-08 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
Other Devices Sharing Product Codes# 
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