Home GUDID M555916006209 Valeo Spacer System
Primary DI M555916006209
Brand Valeo Spacer System
Company SINTX Technologies, Inc.
Model E
Catalog number 91.600.6209
Device description Valeo II C, 16x14 0° 9-10mm -0.5 Stop
Published 2017-12-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name MAX Intervertebral Fusion Device With Bone Graft, Lumbar ODP Intervertebral Fusion Device With Bone Graft, Cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2 ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M555916006209 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Internal spinal fixation procedure kit, single-use A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Height 9 Millimeter Length 16 Millimeter Width 14 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 028629553 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 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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