Home GUDID 00643169118577 CD HORIZON® Spinal System
Primary DI 00643169118577
Brand CD HORIZON® Spinal System
Company MEDTRONIC SOFAMOR DANEK, INC.
Model X0911138
Device description PLUG X0911138 M6 BUTTRESS
Published 2015-06-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY MNH Orthosis, spondylolisthesis spinal fixation MNI ORTHOSIS, SPINAL PEDICLE FIXATION NKB Orthosis, spinal pedicle fixation, for degenerative disc disease OSH Pedicle screw spinal system, adolescent idiopathic scoliosis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2 OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00643169118577 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 00643169118577 00643169118577 643169118577 0643169118577
GMDN Terms# Term, Definition table Term Definition General internal orthopaedic fixation system implantation kit A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 830350380 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810017916191 SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°) ELEVATION SPINE, INC. KWQ 2026-10-27 00810017913763 Saber-C Body (PT), 14x15x5 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913770 Saber-C Body (PT), 14x15x6 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913787 Saber-C Body (PT), 14x15x7 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913794 Saber-C Body (PT), 14x15x8 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913800 Saber-C Body (PT), 14x15x9 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913817 Saber-C Body (PT), 14x15x10 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913824 Saber-C Body (PT), 14x15x5 9 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913930 Saber-C Body (PT), 14x17x10 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913947 Saber-C Body (PT), 14x17x5 9 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913954 Saber-C Body (PT), 14x17x6 9 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913961 Saber-C Body (PT), 14x17x7 9 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913978 Saber-C Body (PT), 14x17x8 9 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913985 Saber-C Body (PT), 14x17x9 9 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017913992 Saber-C Body (PT), 14x17x10 9 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914005 Saber-C Body (PT), 15x18x5 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914012 Saber-C Body (PT), 15x18x6 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914029 Saber-C Body (PT), 15x18x7 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914036 Saber-C Body (PT), 15x18x8 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914043 Saber-C Body (PT), 15x18x9 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914050 Saber-C Body (PT), 15x18x10 6 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914425 Saber-C Body (PT), 14x15x6 12 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914432 Saber-C Body (PT), 14x15x7 12 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914449 Saber-C Body (PT), 14x15x8 12 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914456 Saber-C Body (PT), 14x15x9 12 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914463 Saber-C Body (PT), 14x15x10 12 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00810017914654 Saber-C Body (PT), 15x18x5 12 deg. ELEVATION SPINE, INC. KWQ 2026-10-26 00840606190671 Primus SPINAL ELEMENTS, INC. NKB 2026-10-26 04047844130957 DIPLOMAT SIGNUS Medizintechnik GmbH MNI 2026-10-26 04047844130957 DIPLOMAT SIGNUS Medizintechnik GmbH MNH 2026-10-26
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