HAWKEYE Vertebral Body Replacement (VBR)

GUDID 00840996163224

HAWKEYE,Ti,SPACER,14X16X24, 0DEG

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996163224
NIH Device Record Key909cd1d5-421d-4cd9-a8fa-97050bff4c30
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAWKEYE Vertebral Body Replacement (VBR)
Version Model NumberWT10-14160024
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

Device Dimensions

Width14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996163224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996163224]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2018-01-28

On-Brand Devices [HAWKEYE Vertebral Body Replacement (VBR)]

00840996170826HAWKEYE,PARALLEL CALIPER
00840996163651HAWKEYE,Ti,SPACER,14X16X60, 0DEG
00840996163644HAWKEYE,Ti,SPACER,14X16X59, 0DEG
00840996163637HAWKEYE,Ti,SPACER,14X16X58, 0DEG
00840996163620HAWKEYE,Ti,SPACER,14X16X57, 0DEG
00840996163613HAWKEYE,Ti,SPACER,14X16X56, 0DEG
00840996163606HAWKEYE,Ti,SPACER,14X16X55, 0DEG
00840996163590HAWKEYE,Ti,SPACER,14X16X54, 0DEG
00840996163583HAWKEYE,Ti,SPACER,14X16X53, 0DEG
00840996163507HAWKEYE,Ti,SPACER,14X16X52, 0DEG
00840996163491HAWKEYE,Ti,SPACER,14X16X51, 0DEG
00840996163484HAWKEYE,Ti,SPACER,14X16X50, 0DEG
00840996163477HAWKEYE,Ti,SPACER,14X16X49, 0DEG
00840996163460HAWKEYE,Ti,SPACER,14X16X48, 0DEG
00840996163453HAWKEYE,Ti,SPACER,14X16X47, 0DEG
00840996163446HAWKEYE,Ti,SPACER,14X16X46, 0DEG
00840996163439HAWKEYE,Ti,SPACER,14X16X45, 0DEG
00840996163422HAWKEYE,Ti,SPACER,14X16X44, 0DEG
00840996163415HAWKEYE,Ti,SPACER,14X16X43, 0DEG
00840996163408HAWKEYE,Ti,SPACER,14X16X42, 0DEG
00840996163392HAWKEYE,Ti,SPACER,14X16X41, 0DEG
00840996163385HAWKEYE,Ti,SPACER,14X16X40, 0DEG
00840996163378HAWKEYE,Ti,SPACER,14X16X39, 0DEG
00840996163361HAWKEYE,Ti,SPACER,14X16X38, 0DEG
00840996163354HAWKEYE,Ti,SPACER,14X16X37, 0DEG
00840996163347HAWKEYE,Ti,SPACER,14X16X36, 0DEG
00840996163330HAWKEYE,Ti,SPACER,14X16X35, 0DEG
00840996163323HAWKEYE,Ti,SPACER,14X16X34, 0DEG
00840996163316HAWKEYE,Ti,SPACER,14X16X33, 0DEG
00840996163309HAWKEYE,Ti,SPACER,14X16X32, 0DEG
00840996163293HAWKEYE,Ti,SPACER,14X16X31, 0DEG
00840996163286HAWKEYE,Ti,SPACER,14X16X30, 0DEG
00840996163279HAWKEYE,Ti,SPACER,14X16X29, 0DEG
00840996163262HAWKEYE,Ti,SPACER,14X16X28, 0DEG
00840996163255HAWKEYE,Ti,SPACER,14X16X27, 0DEG
00840996163248HAWKEYE,Ti,SPACER,14X16X26, 0DEG
00840996163231HAWKEYE,Ti,SPACER,14X16X25, 0DEG
00840996163224HAWKEYE,Ti,SPACER,14X16X24, 0DEG
00840996163217HAWKEYE,Ti,SPACER,14X16X23, 0DEG
00840996163200HAWKEYE,Ti,SPACER,14X16X22, 0DEG
00840996163194HAWKEYE,Ti,SPACER,14X16X21, 0DEG
00840996163187HAWKEYE,Ti,SPACER,14X16X20, 0DEG
00840996163170HAWKEYE,Ti,SPACER,14X16X19, 0DEG
00840996163163HAWKEYE,Ti,SPACER,14X16X18, 0DEG
00840996163156HAWKEYE,Ti,SPACER,14X16X17, 0DEG
00840996163149HAWKEYE,Ti,SPACER,14X16X16, 0DEG
00840996163132HAWKEYE,Ti,SPACER,14X16X15, 0DEG
00840996163125HAWKEYE,Ti,SPACER,14X16X14, 0DEG
00840996163118HAWKEYE,Ti,SPACER,14X16X13, 0DEG
00840996163101HAWKEYE,Ti,SPACER,14X16X12, 0DEG
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.