SHARK Lumbar Spacer System

GUDID 00840996170314

SHUTACK SCRAPER

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996170314
• NIH Device Record Key: c090397a-a5d9-4da0-bc00-57feaf8839fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHARK Lumbar Spacer System
• Version Model Number: P070-1600
• 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: 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996170314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140142

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[00840996170314]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-03-10

On-Brand Devices [SHARK Lumbar Spacer System]

• 00840996170314: SHUTACK SCRAPER
• 00840996160667: PLI,SPACER,SHARK,Ti,9,28X18,4 DEG
• 00840996160650: PLI,SPACER,SHARK,Ti,9,28X17,4 DEG
• 00840996160643: PLI,SPACER,SHARK,Ti,9,28X16,4 DEG
• 00840996160636: PLI,SPACER,SHARK,Ti,9,28X15,4 DEG
• 00840996160629: PLI,SPACER,SHARK,Ti,9,28X14,4 DEG
• 00840996160612: PLI,SPACER,SHARK,Ti,9,28X13,4 DEG
• 00840996160605: PLI,SPACER,SHARK,Ti,9,28X12,4 DEG
• 00840996160599: PLI,SPACER,SHARK,Ti,9,28X11,4 DEG
• 00840996160582: PLI,SPACER,SHARK,Ti,9,28X10,4 DEG
• 00840996160575: PLI,SPACER,SHARK,Ti,9,28X9,4 DEG
• 00840996160568: PLI,SPACER,SHARK,Ti,9,28X8,4 DEG
• 00840996160551: PLI,SPACER,SHARK,Ti,9,28X7,4 DEG
• 00840996160544: PLI,SPACER,SHARK,Ti,9,25X18,4 DEG
• 00840996160537: PLI,SPACER,SHARK,Ti,9,25X17,4 DEG
• 00840996160520: PLI,SPACER,SHARK,Ti,9,25X16,4 DEG
• 00840996160513: PLI,SPACER,SHARK,Ti,9,25X15,4 DEG
• 00840996160506: PLI,SPACER,SHARK,Ti,9,25X14,4 DEG
• 00840996160490: PLI,SPACER,SHARK,Ti,9,25X13,4 DEG
• 00840996160483: PLI,SPACER,SHARK,Ti,9,25X12,4 DEG
• 00840996160476: PLI,SPACER,SHARK,Ti,9,25X11,4 DEG
• 00840996160469: PLI,SPACER,SHARK,Ti,9,25X10,4 DEG
• 00840996160452: PLI,SPACER,SHARK,Ti,9,25X9,4 DEG
• 00840996160445: PLI,SPACER,SHARK,Ti,9,25X8,4 DEG
• 00840996160438: PLI,SPACER,SHARK,Ti,9,25X7,4 DEG
• 00840996160421: PLI,SPACER,SHARK,Ti,9,22X18,4 DEG
• 00840996160414: PLI,SPACER,SHARK,Ti,9,22X17,4 DEG
• 00840996160407: PLI,SPACER,SHARK,Ti,9,22X16,4 DEG
• 00840996160391: PLI,SPACER,SHARK,Ti,9,22X15,4 DEG
• 00840996160384: PLI,SPACER,SHARK,Ti,9,22X14,4 DEG
• 00840996160377: PLI,SPACER,SHARK,Ti,9,22X13,4 DEG
• 00840996160360: PLI,SPACER,SHARK,Ti,9,22X12,4 DEG
• 00840996160353: PLI,SPACER,SHARK,Ti,9,22X11,4 DEG
• 00840996160346: PLI,SPACER,SHARK,Ti,9,22X10,4 DEG
• 00840996160339: PLI,SPACER,SHARK,Ti,9,22X9,4 DEG
• 00840996160322: PLI,SPACER,SHARK,Ti,9,22X8,4 DEG
• 00840996160315: PLI,SPACER,SHARK,Ti,9,22X7,4 DEG