FacetLINK MI 80-2901

GUDID 00817329024927

FacetLINK MI Tray

LINKSPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00817329024927
NIH Device Record Key765dffc1-a756-43e4-855c-1df3463d2d6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFacetLINK MI
Version Model Number80-2901
Catalog Number80-2901
Company DUNS067584601
Company NameLINKSPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone1-410-772-5465
Emailcs@linkspine.com
Phone1-410-772-5465
Emailcs@linkspine.com
Phone1-410-772-5465
Emailcs@linkspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817329024927 [Primary]

FDA Product Code

LRPTray, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817329024927]

Moist Heat or Steam Sterilization


[00817329024927]

Moist Heat or Steam Sterilization


[00817329024927]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-11-22
Device Publish Date2018-07-06

On-Brand Devices [FacetLINK MI]

00817329025658FacetLINK MI Set
00817329024927FacetLINK MI Tray
00817329024606Facet Screw Driver Outer Tube
00817329024576Jamshidi Needle
00817329024569Cannulated Torque Handle
00817329024552Reamer
00817329024545Drill Stop
00817329024538Drill
00817329024521Facet Screw Screwdriver
00817329024514Trocar Stylet
00817329024507Trocar Stylet
00817329024491Dilator Handle
00817329024484Dilator 3
00817329024477Dilator 2
00817329024460Dilator 1

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