BLACKBIRD™ Spinal System

GUDID 00840996107754

BLACKBIRD,CONNECTOR,DOMINO-4,3.5-6.0

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996107754
• NIH Device Record Key: a282026e-ad2a-4258-9c50-53b437fa9682
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLACKBIRD™ Spinal System
• Version Model Number: LT30-C35603
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Dimensions

• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996107754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133214

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840996107754]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [BLACKBIRD™ Spinal System]

• 00840996146760: SPCL,BLACKBIRD,3.5 DRILL GUIDE
• 00840996146753: SPCL,BLACKBIRD,TAP SLEEVE
• 00840996146746: SPCL,BLACKBIRD,3.5 DRILL,SINGLE
• 00840996146739: SPCL,BLACKBIRD,3.5 DRILL
• 00840996146722: SPCL,BLACKBIRD,TULIP ADJUSTER
• 00840996146715: SPCL,BLACKBIRD,CURVED PROBE
• 00840996146708: SPCL,BLACKBIRD,SCREWDRIVER
• 00840996146692: SPCL,BLACKBIRD,SET SCREW STARTER
• 00840996146685: SPCL,BLACKBIRD,DRILL GUIDE
• 00840996146678: SPCL,BLACKBIRD,DRILL GUIDE
• 00840996146241: SPCL,BLACKBIRD,ROD PUSHER
• 00840996146029: BLACKBIRD,CONNECTOR,DOMINO-3,3.5-6.0
• 00840996146012: BLACKBIRD, SAFETY SLEEVE
• 00840996136082: BLACKBIRD,ROD CUTTER,3.5,OPEN
• 00840996130721: BLACKBIRD,ROD TEMPLATE
• 00840996130714: BLACKBIRD,T HANDLE,TORQUE,25,AO
• 00840996130707: BLACKBIRD,TAP,4.5
• 00840996130691: BLACKBIRD,LOCKING AWL
• 00840996130684: BLACKBIRD,DRIVER,CROSS CONNECTOR
• 00840996130677: BLACKBIRD,HOOK HOLDER
• 00840996130660: BLACKBIRD,ROD GRIPPER
• 00840996130653: BLACKBIRD,ROD HOLDER
• 00840996130646: BLACKBIRD,PEDICLE PROBE
• 00840996130639: BLACKBIRD,AXIAL,TORQUE,30,3/16 SQ
• 00840996130622: BLACKBIRD,COUNTERTORQUE,TOWER,LG
• 00840996130615: BLACKBIRD,AXIAL HANDLE,RATCHET,AO
• 00840996130608: BLACKBIRD,ROD CUTTER RULER,35-130
• 00840996130592: BLACKBIRD,ROD CUTTER RULER,35-80
• 00840996130585: BLACKBIRD,DRIVER,T-HANDLE,TORQUE,40,1/4
• 00840996130578: BLACKBIRD,DRIVER,TRANSITION CONNECTOR
• 00840996130561: BLACKBIRD,DRIVER,CROSS CONNECTOR
• 00840996130554: BLACKBIRD,SCREWDRIVER,LOCKING
• 00840996130547: BLACKBIRD,INSERTER,ROD-ROD
• 00840996130530: BLACKBIRD,INSITU BENDER,RIGHT
• 00840996130523: BLACKBIRD,INSITU BENDER,LEFT
• 00840996130516: BLACKBIRD,ADJUSTMENT DRIVER
• 00840996130509: BLACKBIRD,CROSS CONNECTOR CALIPER
• 00840996130493: BLACKBIRD,AXIAL HANDLE,LONG,AO
• 00840996130486: BLACKBIRD,AXIAL HANDLE,SHORT,AO
• 00840996130479: BLACKBIRD,PALM HANDLE,TORQUE,25,AO
• 00840996130462: BLACKBIRD,T-HANDLE,TORQUE,30,3/16 SQ
• 00840996130455: BLACKBIRD,BALL TIP PROBE
• 00840996130448: BLACKBIRD,DISTRACTOR
• 00840996130431: BLACKBIRD,COMPRESSOR
• 00840996130424: BLACKBIRD,COUNTERTORQUE,TOWER
• 00840996130417: BLACKBIRD,ROD HOLDER
• 00840996130400: BLACKBIRD,ROD BENDER
• 00840996130394: BLACKBIRD,ROD CUTTER
• 00840996130387: BLACKBIRD,ROD TEMPLATE
• 00840996130370: BLACKBIRD,HOOK INSERTER