Home GUDID 00190361039532 InSpan®
Primary DI 00190361039532
Brand InSpan®
Company SPINEFRONTIER, INC.
Model 11-60082-08
Device description 8mm InSpan Sizing Trial
Published 2016-10-05
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 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 00190361039532 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 00190361039532 00190361039532 190361039532 0190361039532
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.
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
spinefrontier.com