GSO GS1 Spacer

GUDID M9935023080

Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318#

GOLD STANDARD ORTHOPEDICS, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant
Primary Device IDM9935023080
NIH Device Record Key59056a7e-dcaa-42ca-8a34-0a6db86aed08
Commercial Distribution StatusIn Commercial Distribution
Brand NameGSO GS1 Spacer
Version Model Number502308
Company DUNS028008203
Company NameGOLD STANDARD ORTHOPEDICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter
Height8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9935023080 [Primary]

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


[M9935023080]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-23
Device Publish Date2016-07-08

On-Brand Devices [GSO GS1 Spacer]

M9935023141Spacer
M9935023140Spacer
M9935023131Spacer
M9935023130Spacer
M9935023121Spacer
M9935023120Spacer
M9935023111Spacer
M9935023110Spacer
M9935023101Spacer
M9935023100Spacer
M9935023091Spacer
M9935023090Spacer
M9935023081Spacer
M9935023080Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLo
M9935023071Spacer
M9935023070Spacer

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