Lancer Open Pedicle Screw System

GUDID 00840996172936

LANCER,PEDICLE PROBE

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996172936
NIH Device Record Key3b566e02-7630-435b-99a9-99b67bc36951
Commercial Distribution StatusIn Commercial Distribution
Brand NameLancer Open Pedicle Screw System
Version Model NumberM070-0127
Company DUNS078293017
Company NameChoice Spine, LP
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 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

Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996172936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996172936]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-17
Device Publish Date2018-06-16

On-Brand Devices [Lancer Open Pedicle Screw System]

00840996177382Tapered Cannulated T25 Driver
00840996175067LANCER,DRIVER,HEXALOBE,TAPERED
00840996174701LANCER,POSITIONER,TULIP,T-HANDLE
00840996172936LANCER,PEDICLE PROBE
00840996170307LANCER,PROBE-TAP,1/4"COMBINATION

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