SHARK™ Lumbar Spacer System

GUDID 00840996129022

PLI,SPACER,SHARK,9,28X7,4 DEG

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996129022
• NIH Device Record Key: 590c4903-d32d-46e5-858a-17c819e50398
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHARK™ Lumbar Spacer System
• Version Model Number: PP22-28074
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840996129022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140142

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00840996129022]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-03-10

On-Brand Devices [SHARK™ Lumbar Spacer System]

• 00840996129138: PLI,SPACER,SHARK,9,28X18,4 DEG
• 00840996129121: PLI,SPACER,SHARK,9,28X17,4 DEG
• 00840996129114: PLI,SPACER,SHARK,9,28X16,4 DEG
• 00840996129107: PLI,SPACER,SHARK,9,28X15,4 DEG
• 00840996129091: PLI,SPACER,SHARK,9,28X14,4 DEG
• 00840996129084: PLI,SPACER,SHARK,9,28X13,4 DEG
• 00840996129077: PLI,SPACER,SHARK,9,28X12,4 DEG
• 00840996129060: PLI,SPACER,SHARK,9,28X11,4 DEG
• 00840996129053: PLI,SPACER,SHARK,9,28X10,4 DEG
• 00840996129046: PLI,SPACER,SHARK,9,28X9,4 DEG
• 00840996129039: PLI,SPACER,SHARK,9,28X8,4 DEG
• 00840996129022: PLI,SPACER,SHARK,9,28X7,4 DEG
• 00840996129015: PLI,SPACER,SHARK,9,25X18,4 DEG
• 00840996129008: PLI,SPACER,SHARK,9,25X17,4 DEG
• 00840996128995: PLI,SPACER,SHARK,9,25X16,4 DEG
• 00840996128988: PLI,SPACER,SHARK,9,25X15,4 DEG
• 00840996128971: PLI,SPACER,SHARK,9,25X14,4 DEG
• 00840996128964: PLI,SPACER,SHARK,9,25X13,4 DEG
• 00840996128957: PLI,SPACER,SHARK,9,25X12,4 DEG
• 00840996128940: PLI,SPACER,SHARK,9,25X11,4 DEG
• 00840996128933: PLI,SPACER,SHARK,9,25X10,4 DEG
• 00840996128926: PLI,SPACER,SHARK,9,25X9,4 DEG
• 00840996128919: PLI,SPACER,SHARK,9,25X8,4 DEG
• 00840996128902: PLI,SPACER,SHARK,9,25X7,4 DEG
• 00840996128896: PLI,SPACER,SHARK,9,22X18,4 DEG
• 00840996128889: PLI,SPACER,SHARK,9,22X17,4 DEG
• 00840996128872: PLI,SPACER,SHARK,9,22X16,4 DEG
• 00840996128865: PLI,SPACER,SHARK,9,22X15,4 DEG
• 00840996128858: PLI,SPACER,SHARK,9,22X14,4 DEG
• 00840996128841: PLI,SPACER,SHARK,9,22X13,4 DEG
• 00840996128834: PLI,SPACER,SHARK,9,22X12,4 DEG
• 00840996128827: PLI,SPACER,SHARK,9,22X11,4 DEG
• 00840996128810: PLI,SPACER,SHARK,9,22X10,4 DEG
• 00840996128025: PLI,SPACER,SHARK,9,22X9,4 DEG
• 00840996128018: PLI,SPACER,SHARK,9,22X8,4 DEG
• 00840996128001: PLI,SPACER,SHARK,9,22X7,4 DEG
• 00840996117104: PLI,SPACER,SHARK,9,28X18,0 DEG
• 00840996117098: PLI,SPACER,SHARK,9,28X17,0 DEG
• 00840996117081: PLI,SPACER,SHARK,9,28X16,0 DEG
• 00840996117074: PLI,SPACER,SHARK,9,28X15,0 DEG
• 00840996117067: PLI,SPACER,SHARK,9,28X14,0 DEG
• 00840996117050: PLI,SPACER,SHARK,9,28X13,0 DEG
• 00840996117043: PLI,SPACER,SHARK,9,28X12,0 DEG
• 00840996117036: PLI,SPACER,SHARK,9,28X11,0 DEG
• 00840996117029: PLI,SPACER,SHARK,9,28X10,0 DEG
• 00840996117012: PLI,SPACER,SHARK,9,28X9,0 DEG
• 00840996117005: PLI,SPACER,SHARK,9,28X8,0 DEG
• 00840996116992: PLI,SPACER,SHARK,9,28X7,0 DEG
• 00840996116985: PLI,SPACER,SHARK,9,25X18,0 DEG
• 00840996116978: PLI,SPACER,SHARK,9,25X17,0 DEG