Blackbird HLS

GUDID 00840996168236

LAMINOPLASTY,SPACER,6

Choice Spine, LP

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840996168236
• NIH Device Record Key: 58b44e6d-c7a2-4810-8c2a-8082c03b4dd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blackbird HLS
• Version Model Number: LT50-0306
• 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
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Dimensions

• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter
• Width: 6 Millimeter
• Length: 7.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996168236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173215

FDA Product Code

• NQW: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

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

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

Moist Heat or Steam Sterilization

[00840996168236]

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: 2018-01-31

On-Brand Devices [Blackbird HLS]

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