Home GUDID M555258200100 Preference 2
Primary DI M555258200100
Brand Preference 2
Company SINTX Technologies, Inc.
Model E
Catalog number 25-8200-100
Device description ø8.2mm Polyaxial Screw for ø5.5mm Rod, 100mm
Published 2017-12-29
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KWP Appliance, Fixation, Spinal Interlaminal KWQ Appliance, Fixation, Spinal Intervertebral Body MNI Orthosis, Spinal Pedicle Fixation
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 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M555258200100 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 Length 100 Millimeter Outer Diameter 8.2 Millimeter
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 028629553 Device count 1 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 G817103151100 SiNAPTIC Osteotomy Wedge System Inserter - Rev. 0 103-15-1100 2026-04-06 G817103151200 SiNAPTIC Osteotomy Wedge System Tamp - Rev. 0 103-15-1200 2026-04-06 G81711325121605 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121605 2026-04-06 G81711325121606 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121606 2026-04-06 G81711325121607 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121607 2026-04-06 G81711325121608 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121608 2026-04-06 G81711325121610 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121610 2026-04-06 G81711325121612 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121612 2026-04-06 G81711325141805 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141805 2026-04-06 G81711325141806 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141806 2026-04-06 G81711325141807 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141807 2026-04-06 G81711325141808 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141808 2026-04-06 G81711325141810 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141810 2026-04-06 G81711325141812 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141812 2026-04-06 G817S101181806 SiNAPTIC Osteotomy Wedge System Evans Wedge - Rev. 1 S-101-181806 2026-04-06 G817S111121605 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121605 2026-04-05 G817S111121606 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121606 2026-04-05 G817S111121607 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121607 2026-04-05 G817S111121608 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121608 2026-04-05 G817S111121610 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121610 2026-04-05
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