Home GUDID M7405515555 Threshold Solid Pedicle Screw
Primary DI M7405515555
Brand Threshold Solid Pedicle Screw
Company SPINEOLOGY INC.
Model 10-10-80-11
Catalog number 551-5555
Device description Pedicle Screw
Published 2016-08-03
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MNH Orthosis, spondylolisthesis spinal fixation MNI ORTHOSIS, SPINAL PEDICLE FIXATION NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M7405515555 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, sterile An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Length 55 Millimeter
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 033014361 Device count 1 DM exempt true Lot or batch true Expiration date on label 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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