Home GUDID B030ORM17595L0 ORTHROS MIS
Primary DI B030ORM17595L0
Brand ORTHROS MIS
Company CAMBER SPINE TECHNOLOGIES, LLC
Model ORM-1-7595L
Catalog number NA
Device description Ø7.5mm MIS Orthros Dual Thread MIS Screw, 95mm, Long Tower
Published 2024-05-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B030ORM17595L0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-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. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 054205979 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 B030SPO1530020 VARIANT SPO-153-002 2022-11-25 B030TLP420WR0 Alcantara™ Thoracolumbar Plating TLP-420WR 2025-08-01 B030TLP422WR0 Alcantara™ Thoracolumbar Plating TLP-422WR 2025-08-01 B030TLP424WR0 Alcantara™ Thoracolumbar Plating TLP-424WR 2025-08-01 B030TLP426WR0 Alcantara™ Thoracolumbar Plating TLP-426WR 2025-08-01 B030TLP428WR0 Alcantara™ Thoracolumbar Plating TLP-428WR 2025-08-01 B030TLP430WR0 Alcantara™ Thoracolumbar Plating TLP-430WR 2025-08-01 B030TLP432WR0 Alcantara™ Thoracolumbar Plating TLP-432WR 2025-08-01 B030TLP434WR0 Alcantara™ Thoracolumbar Plating TLP-434WR 2025-08-01 B030TLP436WR0 Alcantara™ Thoracolumbar Plating TLP-436WR 2025-08-01 B030TLP438WR0 Alcantara™ Thoracolumbar Plating TLP-438WR 2025-08-01 B030TLP440WR0 Alcantara™ Thoracolumbar Plating TLP-440WR 2025-08-01 B030TLP1000 Alcantara Thoracolumbar Plating TLP-100 NA 2024-07-18 B030TLP2180 Alcantara Thoracolumbar Plating TLP-218 NA 2024-07-18 B030TLP2200 Alcantara Thoracolumbar Plating TLP-220 NA 2024-07-18 B030TLP2220 Alcantara Thoracolumbar Plating TLP-222 NA 2024-07-18 B030TLP2240 Alcantara Thoracolumbar Plating TLP-224 NA 2024-07-18 B030TLP2260 Alcantara Thoracolumbar Plating TLP-226 NA 2024-07-18 B030TLP2280 Alcantara Thoracolumbar Plating TLP-228 NA 2024-07-18 B030TLP2350 Alcantara Thoracolumbar Plating TLP-235 NA 2024-07-18
Other Devices Sharing Product Codes# 
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