SHARK™ Lumbar Spacer System

GUDID 00840996116541

PLI,SPACER,SHARK,28X14,0 DEG

Choice Spine, LP

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID00840996116541
NIH Device Record Key1c3beb88-1039-4b2d-9db3-69ddaf8de314
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHARK™ Lumbar Spacer System
Version Model NumberPP20-28140
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 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
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

Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter
Length28 Millimeter
Height14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996116541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar
MPQCONTAINER, SPECIMEN, URINE, DRUGS OF ABUSE, OVER THE COUNTER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

[00840996116541]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-10-24

On-Brand Devices [SHARK™ Lumbar Spacer System]

00840996129138PLI,SPACER,SHARK,9,28X18,4 DEG
00840996129121PLI,SPACER,SHARK,9,28X17,4 DEG
00840996129114PLI,SPACER,SHARK,9,28X16,4 DEG
00840996129107PLI,SPACER,SHARK,9,28X15,4 DEG
00840996129091PLI,SPACER,SHARK,9,28X14,4 DEG
00840996129084PLI,SPACER,SHARK,9,28X13,4 DEG
00840996129077PLI,SPACER,SHARK,9,28X12,4 DEG
00840996129060PLI,SPACER,SHARK,9,28X11,4 DEG
00840996129053PLI,SPACER,SHARK,9,28X10,4 DEG
00840996129046PLI,SPACER,SHARK,9,28X9,4 DEG
00840996129039PLI,SPACER,SHARK,9,28X8,4 DEG
00840996129022PLI,SPACER,SHARK,9,28X7,4 DEG
00840996129015PLI,SPACER,SHARK,9,25X18,4 DEG
00840996129008PLI,SPACER,SHARK,9,25X17,4 DEG
00840996128995PLI,SPACER,SHARK,9,25X16,4 DEG
00840996128988PLI,SPACER,SHARK,9,25X15,4 DEG
00840996128971PLI,SPACER,SHARK,9,25X14,4 DEG
00840996128964PLI,SPACER,SHARK,9,25X13,4 DEG
00840996128957PLI,SPACER,SHARK,9,25X12,4 DEG
00840996128940PLI,SPACER,SHARK,9,25X11,4 DEG
00840996128933PLI,SPACER,SHARK,9,25X10,4 DEG
00840996128926PLI,SPACER,SHARK,9,25X9,4 DEG
00840996128919PLI,SPACER,SHARK,9,25X8,4 DEG
00840996128902PLI,SPACER,SHARK,9,25X7,4 DEG
00840996128896PLI,SPACER,SHARK,9,22X18,4 DEG
00840996128889PLI,SPACER,SHARK,9,22X17,4 DEG
00840996128872PLI,SPACER,SHARK,9,22X16,4 DEG
00840996128865PLI,SPACER,SHARK,9,22X15,4 DEG
00840996128858PLI,SPACER,SHARK,9,22X14,4 DEG
00840996128841PLI,SPACER,SHARK,9,22X13,4 DEG
00840996128834PLI,SPACER,SHARK,9,22X12,4 DEG
00840996128827PLI,SPACER,SHARK,9,22X11,4 DEG
00840996128810PLI,SPACER,SHARK,9,22X10,4 DEG
00840996128025PLI,SPACER,SHARK,9,22X9,4 DEG
00840996128018PLI,SPACER,SHARK,9,22X8,4 DEG
00840996128001PLI,SPACER,SHARK,9,22X7,4 DEG
00840996117104PLI,SPACER,SHARK,9,28X18,0 DEG
00840996117098PLI,SPACER,SHARK,9,28X17,0 DEG
00840996117081PLI,SPACER,SHARK,9,28X16,0 DEG
00840996117074PLI,SPACER,SHARK,9,28X15,0 DEG
00840996117067PLI,SPACER,SHARK,9,28X14,0 DEG
00840996117050PLI,SPACER,SHARK,9,28X13,0 DEG
00840996117043PLI,SPACER,SHARK,9,28X12,0 DEG
00840996117036PLI,SPACER,SHARK,9,28X11,0 DEG
00840996117029PLI,SPACER,SHARK,9,28X10,0 DEG
00840996117012PLI,SPACER,SHARK,9,28X9,0 DEG
00840996117005PLI,SPACER,SHARK,9,28X8,0 DEG
00840996116992PLI,SPACER,SHARK,9,28X7,0 DEG
00840996116985PLI,SPACER,SHARK,9,25X18,0 DEG
00840996116978PLI,SPACER,SHARK,9,25X17,0 DEG

Trademark Results [SHARK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SHARK
SHARK
98120590 not registered Live/Pending
SharkNinja Operating LLC
2023-08-07
SHARK
SHARK
97939757 not registered Live/Pending
Ormsby Musical Instrument PTY LTD
2023-05-16
SHARK
SHARK
97808306 not registered Live/Pending
SharkNinja Operating LLC
2023-02-23
SHARK
SHARK
97765555 not registered Live/Pending
SharkNinja Operating LLC
2023-01-24
SHARK
SHARK
97509336 not registered Live/Pending
Nod, Inc.
2022-07-19
SHARK
SHARK
97160459 not registered Live/Pending
Xu, Yang
2021-12-07
SHARK
SHARK
97145946 not registered Live/Pending
Newton Lao Leonard & Locke, LLC
2021-11-29
SHARK
SHARK
97131812 not registered Live/Pending
Next Wave Automation, LLC
2021-11-18
SHARK
SHARK
90976022 not registered Live/Pending
SharkNinja Operating LLC
2020-10-13
SHARK
SHARK
90662976 not registered Live/Pending
Shark Apparel
2021-04-22
SHARK
SHARK
90386291 not registered Live/Pending
SharkNinja Operating LLC
2020-12-16
SHARK
SHARK
90386285 not registered Live/Pending
SharkNinja Operating LLC
2020-12-16
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