HARPOON™ Lumbar Spacer System

GUDID 00840996118255

PLI,SPACER,HARPOON,28X13,4 DEG

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996118255
NIH Device Record Key4bed408d-16d3-4053-9e33-d05d401e64cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARPOON™ Lumbar Spacer System
Version Model NumberPP40-28134
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
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Dimensions

Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter
Length28 Millimeter
Height13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996118255 [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

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

Moist Heat or Steam Sterilization

[00840996118255]

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 [HARPOON™ Lumbar Spacer System]

00840996119054PLI,SPACER,HARPOON 9,28X18,4 DEG
00840996119047PLI,SPACER,HARPOON 9,28X18,0 DEG
00840996119030PLI,SPACER,HARPOON 9,28X17,4 DEG
00840996119023PLI,SPACER,HARPOON 9,28X17,0 DEG
00840996119016PLI,SPACER,HARPOON 9,28X16,4 DEG
00840996119009PLI,SPACER,HARPOON 9,28X16,0 DEG
00840996118996PLI,SPACER,HARPOON 9,28X15,4 DEG
00840996118989PLI,SPACER,HARPOON 9,28X15,0 DEG
00840996118972PLI,SPACER,HARPOON 9,28X14,4 DEG
00840996118965PLI,SPACER,HARPOON 9,28X14,0 DEG
00840996118958PLI,SPACER,HARPOON 9,28X13,4 DEG
00840996118941PLI,SPACER,HARPOON 9,28X13,0 DEG
00840996118934PLI,SPACER,HARPOON 9,28X12,4 DEG
00840996118927PLI,SPACER,HARPOON 9,28X12,0 DEG
00840996118910PLI,SPACER,HARPOON 9,28X11,4 DEG
00840996118903PLI,SPACER,HARPOON 9,28X11,0 DEG
00840996118897PLI,SPACER,HARPOON 9,28X10,4 DEG
00840996118880PLI,SPACER,HARPOON 9,28X10,0 DEG
00840996118873PLI,SPACER,HARPOON 9,28X9,4 DEG
00840996118866PLI,SPACER,HARPOON 9,28X9,0 DEG
00840996118859PLI,SPACER,HARPOON 9,28X8,4 DEG
00840996118842PLI,SPACER,HARPOON 9,28X8,0 DEG
00840996118835PLI,SPACER,HARPOON 9,28X7,4 DEG
00840996118828PLI,SPACER,HARPOON 9,28X7,0 DEG
00840996118811PLI,SPACER,HARPOON 9,25X18,4 DEG
00840996118804PLI,SPACER,HARPOON 9,25X18,0 DEG
00840996118798PLI,SPACER,HARPOON 9,25X17,4 DEG
00840996118781PLI,SPACER,HARPOON 9,25X17,0 DEG
00840996118774PLI,SPACER,HARPOON 9,25X16,4 DEG
00840996118767PLI,SPACER,HARPOON 9,25X16,0 DEG
00840996118750PLI,SPACER,HARPOON 9,25X15,4 DEG
00840996118743PLI,SPACER,HARPOON 9,25X15,0 DEG
00840996118736PLI,SPACER,HARPOON 9,25X14,4 DEG
00840996118729PLI,SPACER,HARPOON 9,25X14,0 DEG
00840996118712PLI,SPACER,HARPOON 9,25X13,4 DEG
00840996118705PLI,SPACER,HARPOON 9,25X13,0 DEG
00840996118699PLI,SPACER,HARPOON 9,25X12,4 DEG
00840996118682PLI,SPACER,HARPOON 9,25X12,0 DEG
00840996118675PLI,SPACER,HARPOON 9,25X11,4 DEG
00840996118668PLI,SPACER,HARPOON 9,25X11,0 DEG
00840996118651PLI,SPACER,HARPOON 9,25X10,4 DEG
00840996118644PLI,SPACER,HARPOON 9,25X10,0 DEG
00840996118637PLI,SPACER,HARPOON 9,25X9,4 DEG
00840996118620PLI,SPACER,HARPOON 9,25X9,0 DEG
00840996118613PLI,SPACER,HARPOON 9,25X8,4 DEG
00840996118606PLI,SPACER,HARPOON 9,25X8,0 DEG
00840996118590PLI,SPACER,HARPOON 9,25X7,4 DEG
00840996118583PLI,SPACER,HARPOON 9,25X7,0 DEG
00840996118576PLI,SPACER,HARPOON,32X18,4 DEG
00840996118569PLI,SPACER,HARPOON,32X18,0 DEG

Trademark Results [HARPOON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HARPOON
HARPOON
98671515 not registered Live/Pending
Vista Clara Inc.
2024-07-29
HARPOON
HARPOON
98013566 not registered Live/Pending
HYTTO PTE. LTD.
2023-05-25
HARPOON
HARPOON
97917609 not registered Live/Pending
Darshan-Leitner, Nitsana
2023-05-02
HARPOON
HARPOON
97872650 not registered Live/Pending
Brunswick Corporation
2023-04-04
HARPOON
HARPOON
97395283 not registered Live/Pending
Bonago Medical Solutions LLC
2022-05-04
HARPOON
HARPOON
88716534 not registered Live/Pending
Harpoon Therapeutics, Inc.
2019-12-05
HARPOON
HARPOON
88587427 not registered Live/Pending
Harpoon Therapeutics, Inc.
2019-08-21
HARPOON
HARPOON
87628376 5464299 Live/Registered
Harpoon Medical, Inc.
2017-09-29
HARPOON
HARPOON
87394958 5316124 Live/Registered
Wenzhou Jingwei Trading Co.,Ltd
2017-03-31
HARPOON
HARPOON
87289384 5251034 Live/Registered
Mass. Bay Brewing Company, Inc.
2017-01-04
HARPOON
HARPOON
86900305 5044756 Live/Registered
Mass. Bay Brewing Company, Inc.
2016-02-08
HARPOON
HARPOON
86893476 not registered Dead/Abandoned
Harpoon Therapeutics, Inc.
2016-02-01
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