BLACKHAWK Cervical Spacer System

GUDID 00840996164450

BLACKHAWK,STERILE,LORDOTIC,14X12X9

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996164450
NIH Device Record Keybf632ec6-56a6-4589-8afc-9a564b98bb52
Commercial Distribution StatusIn Commercial Distribution
Brand NameBLACKHAWK Cervical Spacer System
Version Model Number05-090-21-1409
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 Datetrue
Expiration Datetrue
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
GS100840996164450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-27

On-Brand Devices [BLACKHAWK Cervical Spacer System]

00840996168755BLACKHAWK,FINAL LOCKING TOOL
00840996168748BLACKHAWK,ANCHOR REMOVAL TOOL
00840996164924BLACKHAWK,INSERTER STANDARD
00840996164917BLACKHAWK,INSERTER SHORT
00840996164900BLACKHAWK,LONG INSERTER, IMPACTOR
00840996164894BLACKHAWK,SHORT INSERTER,IMPACTOR
00840996164887BLACKHAWK,DOUBLE,IMPACTOR,STND,REWORK
00840996164870BLACKHAWK,DOUBLE,IMPACTOR,SHORT,REWORK
00840996164757BLACKHAWK,STERILE,CONVEX,16X14X9
00840996164740BLACKHAWK,STERILE,CONVEX,16X14X8
00840996164733BLACKHAWK,STERILE,CONVEX,16X14X7
00840996164726BLACKHAWK,STERILE,CONVEX,16X14X6
00840996164719BLACKHAWK,STERILE,CONVEX,16X14X5
00840996164702BLACKHAWK,STERILE,CONVEX,14X12X10
00840996164696BLACKHAWK,STERILE,CONVEX,14X12X9
00840996164689BLACKHAWK,STERILE,CONVEX,14X12X8
00840996164672BLACKHAWK,STERILE,CONVEX,14X12X7
00840996164665BLACKHAWK,STERILE,CONVEX,14X12X6
00840996164658BLACKHAWK,STERILE,CONVEX,14X12X5
00840996164641BLACKHAWK,STERILE,PARALLEL,16X14X10
00840996164634BLACKHAWK,STERILE,PARALLEL,16X14X9
00840996164627BLACKHAWK,STERILE,PARALLEL,16X14X8
00840996164610BLACKHAWK,STERILE,PARALLEL,16X14X7
00840996164603BLACKHAWK,STERILE,PARALLEL,16X14X6
00840996164597BLACKHAWK,STERILE,PARALLEL,16X14X5
00840996164580BLACKHAWK,STERILE,PARALLEL,14X12X10
00840996164573BLACKHAWK,STERILE,PARALLEL,14X12X9
00840996164566BLACKHAWK,STERILE,PARALLEL,14X12X8
00840996164542BLACKHAWK,STERILE,PARALLEL,14X12X6
00840996164535BLACKHAWK,STERILE,PARALLEL,14X12X5
00840996164528BLACKHAWK,STERILE,LORDOTIC,16X14X10
00840996164511BLACKHAWK,STERILE,LORDOTIC,16X14X9
00840996164504BLACKHAWK,STERILE,LORDOTIC,16X14X8
00840996164498BLACKHAWK,STERILE,LORDOTIC,16X14X7
00840996164481BLACKHAWK,STERILE,LORDOTIC,16X14X6
00840996164474BLACKHAWK,STERILE,LORDOTIC,16X14X5
00840996164467BLACKHAWK,STERILE,LORDOTIC,14X12X10
00840996164450BLACKHAWK,STERILE,LORDOTIC,14X12X9
00840996164443BLACKHAWK,STERILE,LORDOTIC,14X12X8
00840996164436BLACKHAWK,STERILE,LORDOTIC,14X12X7
00840996164429BLACKHAWK,STERILE,LORDOTIC,14X12X6
00840996164412BLACKHAWK,STERILE,LORDOTIC,14X12X5
00840996186797BLACKHAWK TI,CON.STERILE,16WX14DX10H
00840996186780BLACKHAWK TI,CON.STERILE,16WX14DX9H
00840996186773BLACKHAWK TI,CON.STERILE,16WX14DX8H
00840996186766BLACKHAWK TI,CON.STERILE,16WX14DX7H
00840996186759BLACKHAWK TI,CON.STERILE,16WX14DX6H
00840996186742BLACKHAWK TI,CON.STERILE,16WX14DX5H
00840996186735BLACKHAWK TI,PAR,STERILE,16WX14DX10H
00840996186728BLACKHAWK TI,PAR,STERILE,16WX14DX9H
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