HORNET™Lumbar Spacer System

GUDID 00840996117210

PLI,SPACER,HORNET,20X18,0 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 Polymeric spinal interbody fusion cage
Primary Device ID00840996117210
NIH Device Record Keybc52211e-bb36-415e-830f-64731928611e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHORNET™Lumbar Spacer System
Version Model NumberPP30-20180
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

Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter
Height18 Millimeter
Length20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996117210 [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

[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

Moist Heat or Steam Sterilization


[00840996117210]

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 [HORNET™Lumbar Spacer System]

00840996117876PLI,SPACER,HORNET,32X18,0 DEG
00840996117869PLI,SPACER,HORNET,32X17,0 DEG
00840996117852PLI,SPACER,HORNET,32X16,0 DEG
00840996117845PLI,SPACER,HORNET,32X15,0 DEG
00840996117838PLI,SPACER,HORNET,32X14,0 DEG
00840996117821PLI,SPACER,HORNET,32X13,0 DEG
00840996117814PLI,SPACER,HORNET,32X12,0 DEG
00840996117807PLI,SPACER,HORNET,32X11,0 DEG
00840996117791PLI,SPACER,HORNET,32X10,0 DEG
00840996117784PLI,SPACER,HORNET,32X9,0 DEG
00840996117777PLI,SPACER,HORNET,32X8,0 DEG
00840996117760PLI,SPACER,HORNET,30X18,0 DEG
00840996117753PLI,SPACER,HORNET,30X17,0 DEG
00840996117746PLI,SPACER,HORNET,30X16,0 DEG
00840996117739PLI,SPACER,HORNET,30X15,0 DEG
00840996117722PLI,SPACER,HORNET,30X14,0 DEG
00840996117715PLI,SPACER,HORNET,30X13,0 DEG
00840996117708PLI,SPACER,HORNET,30X12,0 DEG
00840996117692PLI,SPACER,HORNET,30X11,0 DEG
00840996117685PLI,SPACER,HORNET,30X10,0 DEG
00840996117678PLI,SPACER,HORNET,30X9,0 DEG
00840996117661PLI,SPACER,HORNET,30X8,0 DEG
00840996117654PLI,SPACER,HORNET,28X18,0 DEG
00840996117647PLI,SPACER,HORNET,28X17,0 DEG
00840996117630PLI,SPACER,HORNET,28X16,0 DEG
00840996117623PLI,SPACER,HORNET,28X15,0 DEG
00840996117616PLI,SPACER,HORNET,28X14,0 DEG
00840996117609PLI,SPACER,HORNET,28X13,0 DEG
00840996117593PLI,SPACER,HORNET,28X12,0 DEG
00840996117586PLI,SPACER,HORNET,28X11,0 DEG
00840996117579PLI,SPACER,HORNET,28X10,0 DEG
00840996117562PLI,SPACER,HORNET,28X9,0 DEG
00840996117555PLI,SPACER,HORNET,28X8,0 DEG
00840996117548PLI,SPACER,HORNET,25X18,4 DEG
00840996117531PLI,SPACER,HORNET,25X18,0 DEG
00840996117524PLI,SPACER,HORNET,25X17,4 DEG
00840996117517PLI,SPACER,HORNET,25X17,0 DEG
00840996117500PLI,SPACER,HORNET,25X16,4 DEG
00840996117494PLI,SPACER,HORNET,25X16,0 DEG
00840996117487PLI,SPACER,HORNET,25X15,4 DEG
00840996117470PLI,SPACER,HORNET,25X15,0 DEG
00840996117463PLI,SPACER,HORNET,25X14,4 DEG
00840996117456PLI,SPACER,HORNET,25X14,0 DEG
00840996117449PLI,SPACER,HORNET,25X13,4 DEG
00840996117432PLI,SPACER,HORNET,25X13,0 DEG
00840996117425PLI,SPACER,HORNET,25X12,4 DEG
00840996117418PLI,SPACER,HORNET,25X12,0 DEG
00840996117401PLI,SPACER,HORNET,25X11,4 DEG
00840996117395PLI,SPACER,HORNET,25X11,0 DEG
00840996117388PLI,SPACER,HORNET,25X10,4 DEG

Trademark Results [HORNET]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HORNET
HORNET
98020995 not registered Live/Pending
Ritchie Engineering Company, Inc.
2023-05-31
HORNET
HORNET
97874442 not registered Live/Pending
Danuser Machine Company, LLC
2023-04-05
HORNET
HORNET
97874324 not registered Live/Pending
Danuser Machine Company, LLC
2023-04-05
HORNET
HORNET
97605925 not registered Live/Pending
PMK Mess- und Kommunikationstechnik GmbH
2022-09-25
HORNET
HORNET
97313127 not registered Live/Pending
Hornet Animations, Inc.
2022-03-15
HORNET
HORNET
97139065 not registered Live/Pending
Qingjun Wei
2021-11-23
HORNET
HORNET
97031000 not registered Live/Pending
Hornet Watersports International Limited
2021-09-16
HORNET
HORNET
90544554 not registered Live/Pending
Intrinsic Minds, LLC
2021-02-24
HORNET
HORNET
90489978 not registered Live/Pending
PARSONS XTREME GOLF, LLC
2021-01-26
HORNET
HORNET
90314595 not registered Live/Pending
Springfield, Inc.
2020-11-12
HORNET
HORNET
90265964 not registered Live/Pending
Optical Support Ltd
2020-10-20
HORNET
HORNET
90010748 not registered Live/Pending
Hornet Animations, Inc.
2020-06-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.