BLACKBIRD Spinal System

GUDID 00840996175500

BLACKBIRD,SCREW,POLYAXIAL,3.5X12

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996175500
NIH Device Record Keya8a9496d-2e03-4493-bcdd-c308c6f43353
Commercial Distribution StatusIn Commercial Distribution
Brand NameBLACKBIRD Spinal System
Version Model NumberLT11-3512
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

Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter
Outer Diameter3.5 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996175500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

[00840996175500]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-18
Device Publish Date2018-11-17

On-Brand Devices [BLACKBIRD Spinal System]

00840996175609BLACKBIRD,SCREW,POLYAXIAL,3.5X32
00840996175593BLACKBIRD,SCREW,POLYAXIAL,3.5X30
00840996175586BLACKBIRD,SCREW,POLYAXIAL,3.5X28
00840996175579BLACKBIRD,SCREW,POLYAXIAL,3.5X26
00840996175562BLACKBIRD,SCREW,POLYAXIAL,3.5X24
00840996175555BLACKBIRD,SCREW,POLYAXIAL,3.5X22
00840996175548BLACKBIRD,SCREW,POLYAXIAL,3.5X20
00840996175531BLACKBIRD,SCREW,POLYAXIAL,3.5X18
00840996175524BLACKBIRD,SCREW,POLYAXIAL,3.5X16
00840996175517BLACKBIRD,SCREW,POLYAXIAL,3.5X14
00840996175500BLACKBIRD,SCREW,POLYAXIAL,3.5X12
00840996175494BLACKBIRD,SCREW,POLYAXIAL,3.5X10
00840996175487BLACKBIRD,SCREW,POLYAXIAL,4.0X32
00840996175470BLACKBIRD,SCREW,POLYAXIAL,4.0X30
00840996175463BLACKBIRD,SCREW,POLYAXIAL,4.0X28
00840996175456BLACKBIRD,SCREW,POLYAXIAL,4.0X26
00840996175449BLACKBIRD,SCREW,POLYAXIAL,4.0X24
00840996175432BLACKBIRD,SCREW,POLYAXIAL,4.0X22
00840996175425BLACKBIRD,SCREW,POLYAXIAL,4.0X20
00840996175418BLACKBIRD,SCREW,POLYAXIAL,4.0X18
00840996175401BLACKBIRD,SCREW,POLYAXIAL,4.0X16
00840996175395BLACKBIRD,SCREW,POLYAXIAL,4.0X14
00840996175388BLACKBIRD,SCREW,POLYAXIAL,4.0X12
00840996175371BLACKBIRD,SCREW,POLYAXIAL,4.0X10
00840996175364BLACKBIRD,SCREW,POLYAXIAL,4.5X40
00840996175357BLACKBIRD,SCREW,POLYAXIAL,4.5X38
00840996175340BLACKBIRD,SCREW,POLYAXIAL,4.5X36
00840996175333BLACKBIRD,SCREW,POLYAXIAL,4.5X34
00840996175326BLACKBIRD,SCREW,POLYAXIAL,4.5X32
00840996175319BLACKBIRD,SCREW,POLYAXIAL,4.5X30
00840996175302BLACKBIRD,SCREW,POLYAXIAL,4.5X28
00840996175296BLACKBIRD,SCREW,POLYAXIAL,4.5X26
00840996175289BLACKBIRD,SCREW,POLYAXIAL,4.5X24
00840996175272BLACKBIRD,SCREW,POLYAXIAL,4.5X22
00840996175265BLACKBIRD,SCREW,POLYAXIAL,4.5X20
00840996175258BLACKBIRD,SCREW,POLYAXIAL,4.5X18
00840996175241BLACKBIRD,SCREW,POLYAXIAL,4.5X16
00840996175234BLACKBIRD,SCREW,POLYAXIAL,4.5X14
00840996175227BLACKBIRD,SCREW,POLYAXIAL,4.5X12
00840996175210BLACKBIRD,SCREW,POLYAXIAL,4.5X10
00840996175203BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,3.5X30
00840996175197BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,3.5X28
00840996175180BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,3.5X26
00840996175173BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,3.5X24
00840996175166BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,3.5X22
00840996175159BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,3.5X20
00840996175142BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,3.5X18
00840996175135BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,4.0X26
00840996175128BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,4.0X30
00840996175111BLACKBIRD,SCREW,POLYAXIAL,SMOOTH,4.0X28
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