Home GUDID 00190361028284 InSpan
Primary DI 00190361028284
Brand InSpan
Company SPINEFRONTIER, INC.
Model 01-61100-1845
Device description SLIM, INSPAN, ISP PLATE ASSEMBLY
Published 2021-01-25
Public version status New
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 KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190361028284 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 00190361028284 00190361028284 190361028284 0190361028284
GMDN Terms# Term, Definition table Term Definition Interspinous spinal fixation implant An implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 45 Millimeter Width 18 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 002003243 Device count 1 DM exempt true Lot or batch true 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 00763000777500 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2026-10-25 00763000777623 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2026-10-25 00763000786434 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2026-10-25 00763000777616 CD HORIZON® Fenestrated Screw Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2026-10-23 00840466901011 Primus SPINAL ELEMENTS, INC. KWP 2026-10-22 00840019978156 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978163 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978170 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978187 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978194 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978200 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978217 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978224 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978231 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978248 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978255 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978262 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978279 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978286 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978293 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978309 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978316 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978323 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978330 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978347 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978354 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978361 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978378 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978385 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19 00840019978392 Reform Ti PRECISION SPINE, INC. KWP 2026-10-19
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