TIGER SHARK Cervical System

GUDID 00840996182010

TIGER SHARK,STERILE,C,18X15X11,6 DEG

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996182010
NIH Device Record Keyd56559ce-9189-4271-8c15-ad2ec92f2d13
Commercial Distribution StatusIn Commercial Distribution
Brand NameTIGER SHARK Cervical System
Version Model NumberS-TC10-1815611
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996182010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

[00840996182010]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-03

On-Brand Devices [TIGER SHARK Cervical System]

00840996182027TIGER SHARK,STERILE,C,18X15X12,6 DEG
00840996182010TIGER SHARK,STERILE,C,18X15X11,6 DEG
00840996182003TIGER SHARK,STERILE,C,18X15X10,6 DEG
00840996181990TIGER SHARK,STERILE,C,18X15X9,6 DEG
00840996181983TIGER SHARK,STERILE,C,18X15X8,6 DEG
00840996181976TIGER SHARK,STERILE,C,18X15X7,6 DEG
00840996181969TIGER SHARK,STERILE,C,18X15X6,6 DEG
00840996181952TIGER SHARK,STERILE,C,18X15X5,6 DEG
00840996181945TIGER SHARK,STERILE,C,18X15X12,0 DEG
00840996181938TIGER SHARK,STERILE,C,18X15X11,0 DEG
00840996181921TIGER SHARK,STERILE,C,18X15X10,0 DEG
00840996181914TIGER SHARK,STERILE,C,18X15X9,0 DEG
00840996181907TIGER SHARK,STERILE,C,18X15X8,0 DEG
00840996181891TIGER SHARK,STERILE,C,18X15X7,0 DEG
00840996181884TIGER SHARK,STERILE,C,18X15X6,0 DEG
00840996181877TIGER SHARK,STERILE,C,18X15X5,0 DEG
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