Home GUDID M7401001305 Rampart One Lumbar Interbody Fusion System
Primary DI M7401001305
Brand Rampart One Lumbar Interbody Fusion System
Company SPINEOLOGY INC.
Model 102-63-02
Catalog number 100-1305
Device description 15 degree Trial Block Assembly
Published 2025-04-21
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M7401001305 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical implant/trial-implant/sizer holder, reusable A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable 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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