HARPOON Lumbar Spacer System

GUDID 00840996148214

PLI,SPACER,HARPOON,36X10,4 DEG

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996148214
NIH Device Record Key430b54e2-d0a3-427e-b3f2-8e7abc3e34ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARPOON Lumbar Spacer System
Version Model NumberPP40-36104
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
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

Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter
Length36 Millimeter
Height10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996148214 [Primary]

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

[00840996148214]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2017-02-16

On-Brand Devices [HARPOON Lumbar Spacer System]

00840996148214PLI,SPACER,HARPOON,36X10,4 DEG
00840996148207PLI,SPACER,HARPOON,36X12,4 DEG
00840996148191PLI,SPACER,HARPOON,36X13,4 DEG
00840996181853PLI,SPACER,HARPOON,36X9, 4 DEG
00840996181846PLI,SPACER,HARPOON,36X14,4 DEG
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.