SHARK Lumbar Spacer System

GUDID 00840996160391

PLI,SPACER,SHARK,Ti,9,22X15,4 DEG

Choice Spine, LP

Metallic spinal fusion cage, non-sterile
Primary Device ID00840996160391
NIH Device Record Keyfdfdaa0d-33d0-4ae1-b96e-d1d333beb8b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHARK Lumbar Spacer System
Version Model NumberPT22-22154
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exempttrue
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

Customer Support Contacts

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

Device Dimensions

Height15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996160391 [Primary]

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996160391]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-06-28

On-Brand Devices [SHARK Lumbar Spacer System]

00840996170314SHUTACK SCRAPER
00840996160667PLI,SPACER,SHARK,Ti,9,28X18,4 DEG
00840996160650PLI,SPACER,SHARK,Ti,9,28X17,4 DEG
00840996160643PLI,SPACER,SHARK,Ti,9,28X16,4 DEG
00840996160636PLI,SPACER,SHARK,Ti,9,28X15,4 DEG
00840996160629PLI,SPACER,SHARK,Ti,9,28X14,4 DEG
00840996160612PLI,SPACER,SHARK,Ti,9,28X13,4 DEG
00840996160605PLI,SPACER,SHARK,Ti,9,28X12,4 DEG
00840996160599PLI,SPACER,SHARK,Ti,9,28X11,4 DEG
00840996160582PLI,SPACER,SHARK,Ti,9,28X10,4 DEG
00840996160575PLI,SPACER,SHARK,Ti,9,28X9,4 DEG
00840996160568PLI,SPACER,SHARK,Ti,9,28X8,4 DEG
00840996160551PLI,SPACER,SHARK,Ti,9,28X7,4 DEG
00840996160544PLI,SPACER,SHARK,Ti,9,25X18,4 DEG
00840996160537PLI,SPACER,SHARK,Ti,9,25X17,4 DEG
00840996160520PLI,SPACER,SHARK,Ti,9,25X16,4 DEG
00840996160513PLI,SPACER,SHARK,Ti,9,25X15,4 DEG
00840996160506PLI,SPACER,SHARK,Ti,9,25X14,4 DEG
00840996160490PLI,SPACER,SHARK,Ti,9,25X13,4 DEG
00840996160483PLI,SPACER,SHARK,Ti,9,25X12,4 DEG
00840996160476PLI,SPACER,SHARK,Ti,9,25X11,4 DEG
00840996160469PLI,SPACER,SHARK,Ti,9,25X10,4 DEG
00840996160452PLI,SPACER,SHARK,Ti,9,25X9,4 DEG
00840996160445PLI,SPACER,SHARK,Ti,9,25X8,4 DEG
00840996160438PLI,SPACER,SHARK,Ti,9,25X7,4 DEG
00840996160421PLI,SPACER,SHARK,Ti,9,22X18,4 DEG
00840996160414PLI,SPACER,SHARK,Ti,9,22X17,4 DEG
00840996160407PLI,SPACER,SHARK,Ti,9,22X16,4 DEG
00840996160391PLI,SPACER,SHARK,Ti,9,22X15,4 DEG
00840996160384PLI,SPACER,SHARK,Ti,9,22X14,4 DEG
00840996160377PLI,SPACER,SHARK,Ti,9,22X13,4 DEG
00840996160360PLI,SPACER,SHARK,Ti,9,22X12,4 DEG
00840996160353PLI,SPACER,SHARK,Ti,9,22X11,4 DEG
00840996160346PLI,SPACER,SHARK,Ti,9,22X10,4 DEG
00840996160339PLI,SPACER,SHARK,Ti,9,22X9,4 DEG
00840996160322PLI,SPACER,SHARK,Ti,9,22X8,4 DEG
00840996160315PLI,SPACER,SHARK,Ti,9,22X7,4 DEG
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