Blackbird HLS

GUDID 00840996168458

LAMINOPLASTY,SCREW,ST,2.4X6

Choice Spine, LP

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00840996168458
NIH Device Record Keybb61c4d5-8ca7-4a0e-a2ed-231adfc1fdc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlackbird HLS
Version Model NumberLT50-T2406
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

Device Dimensions

Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter
Outer Diameter2.4 Millimeter
Length6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996168458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

[00840996168458]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-31

On-Brand Devices [Blackbird HLS]

00840996174732LAMINOPLASTY,AWL,4MM
00840996174725LAMINOPLASTY,AWL,8MM
00840996170758LAMIN,HINGED HOOK,KICKSTAND,MINIPLATE,14
00840996170741LAMIN,HINGED HOOK,KICKSTAND,MINIPLATE,12
00840996170734LAMIN,HINGED HOOK,KICKSTAND,MINIPLATE,10
00840996170727LAMIN.,HINGED HOOK,KICKSTAND,MINIPLATE,8
00840996170710LAMIN.,HINGED HOOK,KICKSTAND,MINIPLATE,6
00840996170673LAMINOPLASTY, BENDING/CUTTING PLIARS
00840996170260LAMINOPLASTY,HINGED PLATE
00840996170253LAMINOPLASTY,HINGED MINIPLATE,14
00840996170246LAMINOPLASTY,HINGED MINIPLATE,12
00840996170239LAMINOPLASTY,HINGED MINIPLATE,10
00840996170222LAMINOPLASTY,HINGED MINIPLATE,8
00840996170215LAMINOPLASTY,HINGED MINIPLATE,6
00840996170208LAMINOPLASTY,HINGED MINIPLATE,4
00840996168601LAMINOPLASTY, LAMINA LIFTER
00840996168595LAMINOPLASTY, SCREW DRIVER
00840996168588LAMINOPLASTY, DRILL, FIXED
00840996168571LAMINOPLASTY, DRILL GUIDE, VARIABLE
00840996168564LAMINOPLASTY, TRIAL, 12-14
00840996168557LAMINOPLASTY, TRIAL, 8-10
00840996168540LAMINOPLASTY, TRIAL, 4-6
00840996168533LAMINOPLASTY,RESCUE SCREW, 2.8X12
00840996168526LAMINOPLASTY,RESCUE SCREW, 2.8X10
00840996168519LAMINOPLASTY,RESCUE SCREW, 2.8X8
00840996168502LAMINOPLASTY,RESCUE SCREW, 2.8X6
00840996168496LAMINOPLASTY,RESCUE SCREW, 2.8X4
00840996168489LAMINOPLASTY,SCREW,ST,2.4X12
00840996168472LAMINOPLASTY,SCREW,ST,2.4X10
00840996168465LAMINOPLASTY,SCREW,ST,2.4X8
00840996168458LAMINOPLASTY,SCREW,ST,2.4X6
00840996168441LAMINOPLASTY,SCREW,ST,2.4X4
00840996168434LAMINOPLASTY,SCREW,SD,2.4X12
00840996168427LAMINOPLASTY,SCREW,SD,2.4X10
00840996168410LAMINOPLASTY,SCREW,SD,2.4X8
00840996168403LAMINOPLASTY,SCREW,SD,2.4X6
00840996168397LAMINOPLASTY,SCREW,SD,2.4X4
00840996168380LAMINOPLASTY, FIXED HINGE PLATE
00840996168373LAMINOPLASTY,FIXED ALLOGRAFT PLATE,14
00840996168366LAMINOPLASTY,FIXED ALLOGRAFT PLATE,12
00840996168359LAMINOPLASTY,FIXED ALLOGRAFT PLATE,10
00840996168342LAMINOPLASTY,FIXED ALLOGRAFT PLATE,8
00840996168335LAMINOPLASTY,FIXED ALLOGRAFT PLATE,6
00840996168328LAMINOPLASTY,FIXED ALLOGRAFT PLATE,4
00840996168311LAMINOPLASTY,PLATE HOLDER,20 DEG
00840996168304LAMINOPLASTY,PLATE HOLDER,65 DEG
00840996168298LAMINOPLASTY,PLATE HOLDER,SLEEVE
00840996168281AXIAL,RATCHET,AO,W/SPIN CAP,HANDLE
00840996168274LAMINOPLASTY,SPACER,14
00840996168267LAMINOPLASTY,SPACER,12
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