TiGER SHARK Interbody Fusion System

GUDID 00840996176163

TIGER SHARK, STRAIGHT,STERILE,11X24X13,6

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996176163
NIH Device Record Key03f5574c-8dac-4265-a05c-d4178fd2d0ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiGER SHARK Interbody Fusion System
Version Model NumberS-PT36-24136
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 Datetrue
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
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 Dimensions

Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter
Width11 Millimeter
Height13 Millimeter
Length24 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996176163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

[00840996176163]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-05
Device Publish Date2019-01-05

On-Brand Devices [TiGER SHARK Interbody Fusion System]

00840996176989TIGER SHARK, STRAIGHT,STERILE,11X32X14,6
00840996176873Tiger Shark Cage Inserter
00840996176866Parallel 16X14,0 deg Dual trials 11&12H
00840996176859Lor 16X14,0 deg Dual trials 9&10H
00840996176842Parallel 16X14,6 deg Dual trials 7&8H
00840996176835Parallel 16X14,0 deg Dual trials 5&6H
00840996176828Parallel 14X12,0 deg Dual trials 11&11H
00840996176811Parallel 14X12,0 deg Dual trials 9&10 H
00840996176804Parallel 14X12,0 deg Dual trials 7&8H
00840996176798Parallel 14X12,0 deg Dual trials 5&6H
00840996176781Lor 16x14,6 deg Dual trials 11&12 H
00840996176774Lor 16X14,6 deg Dual trials 9&10H
00840996176767Lor 16X14,6 deg Dual trials 7&8H
00840996176750Lor 16x14,6 deg Dual trials 5&6H
00840996176743Lor 14X12,6 deg Dual trials 11&12H
00840996176736Lor 14X12,6 deg Dual trials 9&10H
00840996176729Lor 14X12,6 deg Dual trials 7&8H
00840996176378TIGER SHARK, STRAIGHT,STERILE,11X32X18,6
00840996176361TIGER SHARK, STRAIGHT,STERILE,11X32X18,6
00840996176354TIGER SHARK, STRAIGHT,STERILE,11X32X17,6
00840996176347TIGER SHARK, STRAIGHT,STERILE,11X32X16,6
00840996176330TIGER SHARK, STRAIGHT,STERILE,11X32X15,6
00840996176323TIGER SHARK, STRAIGHT,STERILE,11X32X14,6
00840996176316TIGER SHARK, STRAIGHT,STERILE,11X32X13,6
00840996176309TIGER SHARK, STRAIGHT,STERILE,11X32X12,6
00840996176293TIGER SHARK, STRAIGHT,STERILE,11X32X11,6
00840996176286TIGER SHARK, STRAIGHT,STERILE,11X28X17,6
00840996176279TIGER SHARK, STRAIGHT,STERILE,11X28X16,6
00840996176262TIGER SHARK, STRAIGHT,STERILE,11X28X15,6
00840996176255TIGER SHARK, STRAIGHT,STERILE,11X28X14,6
00840996176248TIGER SHARK, STRAIGHT,STERILE,11X28X13,6
00840996176231TIGER SHARK, STRAIGHT,STERILE,11X28X12,6
00840996176224TIGER SHARK, STRAIGHT,STERILE,11X28X11,6
00840996176217TIGER SHARK, STRAIGHT,STERILE,11X28X10,6
00840996176200TIGER SHARK, STRAIGHT,STERILE,11X24X17,6
00840996176194TIGER SHARK, STRAIGHT,STERILE,11X24X16,6
00840996176187TIGER SHARK, STRAIGHT,STERILE,11X24X15,6
00840996176170TIGER SHARK, STRAIGHT,STERILE,11X24X14,6
00840996176163TIGER SHARK, STRAIGHT,STERILE,11X24X13,6
00840996176156TIGER SHARK, STRAIGHT,STERILE,11X24X12,6
00840996176149TIGER SHARK, STRAIGHT,STERILE,11X24X11,6
00840996176132TIGER SHARK, STRAIGHT,STERILE,11X24X10,6
00840996176125TIGER SHARK, STRAIGHT,STERILE,11X24X9, 6
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.