Home GUDID 00840019937726 Reform Midline Cortical Screw System
Primary DI 00840019937726
Brand Reform Midline Cortical Screw System
Company PRECISION SPINE, INC.
Model 59-BK-0505
Catalog number 59-BK-0505
Device description Ø5.5mm Bone Screw Build Kit - Pedicular
Published 2019-09-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00840019937726 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840019937726 00840019937726 840019937726 0840019937726
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 079398589 Device count 1 DM exempt true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840019904650 Slimplicity Anterior Cervical Plate System ACP118 ACP118 2019-04-11 00840019904667 Slimplicity Anterior Cervical Plate System ACP120 ACP120 2019-04-11 00840019904674 Slimplicity Anterior Cervical Plate System ACP122 ACP122 2019-04-11 00840019904681 Slimplicity Anterior Cervical Plate System ACP124 ACP124 2019-04-11 00840019904698 Slimplicity Anterior Cervical Plate System ACP126 ACP126 2019-04-11 00840019904704 Slimplicity Anterior Cervical Plate System ACP128 ACP128 2019-04-11 00815362021446 Slimplicity Anterior Cervical Plate System 08-9020 08-9020 2019-04-01 00815362021453 Slimplicity Anterior Cervical Plate System 08-9021 08-9021 2019-04-01 00815362021460 Slimplicity Anterior Cervical Plate System 08-9024 08-9024 2019-04-01 00815362021477 Slimplicity Anterior Cervical Plate System 08-9025 08-9025 2019-04-01 00815362021484 Slimplicity Anterior Cervical Plate System 08-9026 08-9026 2019-04-01 00815362021729 Slimplicity Anterior Cervical Plate System 50-0018 50-0018 2019-04-01 00815362021088 Slimplicity Anterior Cervical Plate System 08-0112 08-0112 2019-03-29 00815362021118 Slimplicity Anterior Cervical Plate System 08-0118 08-0118 2019-03-29 00815362021125 Slimplicity Anterior Cervical Plate System 08-0120 08-0120 2019-03-29 00815362021132 Slimplicity Anterior Cervical Plate System 08-0122 08-0122 2019-03-29 00815362021149 Slimplicity Anterior Cervical Plate System 08-0124 08-0124 2019-03-29 00815362021156 Slimplicity Anterior Cervical Plate System 08-0126 08-0126 2019-03-29 00815362021163 Slimplicity Anterior Cervical Plate System 08-0128 08-0128 2019-03-29 00815362021170 Slimplicity Anterior Cervical Plate System 08-0226 08-0226 2019-03-29
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