Blackbird

GUDID 00840996187367

BLACKBIRD,CORONAL BENDER,LFT,6.0

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996187367
• NIH Device Record Key: 2dcb0ae2-6364-45b8-be0e-983790f8a4f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blackbird
• Version Model Number: L070-0068L
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996187367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133214

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

[00840996187367]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [Blackbird]

• 00840996187534: BLACKBIRD, TULIP GRABBER
• 00840996187527: BLACKBIRD,2.5 TAP
• 00840996187367: BLACKBIRD,CORONAL BENDER,LFT,6.0
• 00840996187350: BLACKBIRD,CORONAL BENDER,LFT,5.5
• 00840996187343: BLACKBIRD,CORONAL BENDER,LFT,3.5
• 00840996187336: BLACKBIRD,CORONAL BENDER, RT,6.0
• 00840996187329: BLACKBIRD,CORONAL BENDER, RT,5.5
• 00840996187312: BLACKBIRD,CORONAL BENDER, RT,3.5
• 00840996186254: Blackbird,Retain Driver,Tapered Tip
• 00840996186247: Blackbird,Retaining Driver,Tip
• 00840996186186: BLACKBIRD,NAVIGATION DRIVER,NVL
• 00840996185479: Blackbird,SetScrewStarter,Tapered Tip
• 00840996183598: Blackbird,Navigation,Driver
• 00840996183581: Blackbird,navigation,Pedicle Probe
• 00840996183574: Blackbird,navigation,Tap,4.0
• 00840996183567: Blackbird,navigation,Tap,3.5
• 00840996183550: Blackbird
• 00840996183543: BLACKBIRD,NAVIGATION,DRIVER