Tiger Shark Spinal System

GUDID 00840996177535

TIGER SHARK STRAIGHT TRIAL 11x28x15 6DEG

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996177535
NIH Device Record Key739b760d-22f1-4845-8f79-d5e9f98cfb57
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiger Shark Spinal System
Version Model NumberP070-28156W
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 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.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996177535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996177535]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-28
Device Publish Date2019-06-20

On-Brand Devices [Tiger Shark Spinal System]

00840996177641TIGER SHARK STRAIGHT TRIAL 11x32X18-6DEG
00840996177634TIGER SHARK STRAIGHT TRIAL 11x32X18-6DEG
00840996177627TIGER SHARK STRAIGHT TRIAL 11x32X17-6DEG
00840996177610TIGER SHARK STRAIGHT TRIAL 11x32X16 6DEG
00840996177603TIGER SHARK STRAIGHT TRIAL 11x32X15-6DEG
00840996177597TIGER SHARK STRAIGHT TRIAL 11x32X14-6DEG
00840996177580TIGER SHARK STRAIGHT TRIAL 11x32X13-6DEG
00840996177573TIGER SHARK STRAIGHT TRIAL 11x32X12-6DEG
00840996177566TIGER SHARK STRAIGHT TRIAL 11x32X11-6DEG
00840996177559TIGER SHARK STRAIGHT TRIAL 11x28x17 6DEG
00840996177542TIGER SHARK STRAIGHT TRIAL 11x28x16 6DEG
00840996177535TIGER SHARK STRAIGHT TRIAL 11x28x15 6DEG
00840996177528TIGER SHARK STRAIGHT TRIAL 11x28x14 6DEG
00840996177511TIGER SHARK STRAIGHT TRIAL 11x28x13 6deg
00840996177504TIGER SHARK STRAIGHT TRIAL 11x28x12 6deg
00840996177498TIGER SHARK STRAIGHT TRIAL 11x28x11-6deg
00840996177481TIGER SHARK STRAIGHT TRIAL 11x28x10 6deg
00840996177474TIGER SHARK,STRAIGHT,TRIAL,9X32X16-6 DEG
00840996177467TIGER SHARK,STRAIGHT,TRIAL,9X32X15-6 DEG
00840996177450TIGER SHARK,STRAIGHT,TRIAL,9X24X14,6 DEG
00840996177443TIGER SHARK,STRAIGHT,TRIAL,9X32X13,6 DEG
00840996177436TIGER SHARK,STRAIGHT,TRIAL,9X32X12,6 DEG
00840996177429Tiger Shark Trial 11X24x11-6 deg
00840996177412Tiger Shark Trial 11X24x10-6 deg
00840996177405Tiger Shark Trial 11X24x9-6 deg
00840996177276Tiger Shark, Inserter,Angled, Right
00840996177269TigerShark,Inserter, Angled,Left
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