TOMCAT™ Cervical Spinal System

GUDID 00840996126007

TOMCAT,TRIAL,14X12X4,12

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996126007
• NIH Device Record Key: 5ea5b989-978b-4481-b87a-0a520ef00803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOMCAT™ Cervical Spinal System
• Version Model Number: R070-1412412
• 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	00840996126007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152515

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996126007]

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: 2016-02-26

On-Brand Devices [TOMCAT™ Cervical Spinal System]

• 00840996148016: SPCL,TOMCAT,TRIAL,NO STOP,16x14x8 5H
• 00840996148009: SPCL,TOMCAT,TRIAL,NO STOP,16x14x4 5H
• 00840996147996: SPCL,TOMCAT,TRIAL,NO STOP,14x12x8 5H
• 00840996147989: SPCL,TOMCAT,TRIAL,NO STOP,14x12x4 5H
• 00840996147972: SPCL,TOMCAT,UNIVERSAL JOINT DRIVER,SPLI
• 00840996147965: SPCL,TOMCAT,ANGLED DRIVER GRIP
• 00840996147958: SPCL,TOMCAT,AWL,ANGLED,LONG
• 00840996147941: SPCL,TOMCAT,AWL,STRAIGHT,LONG
• 00840996147934: SPCL,TOMCAT,U-JOINT FORCEPS
• 00840996147927: SPCL,TOMCAT,STP,MODIFIED
• 00840996147910: SPCL,TOMCAT,16X14 RASP,STOP REMOVED
• 00840996147903: SPCL,TOMCAT,14X12 RASP,STOP REMOVED
• 00840996146234: TOMCAT,TAMP
• 00840996146227: TOMCAT,DRIVER,U-JOINT,SPLIT TIP
• 00840996146210: TOMCAT,DRIVER,SPLIT TIP
• 00840996136167: TOMCAT,0P GUIDE,TABS, 12 HEIGHT
• 00840996136150: TOMCAT,0P GUIDE,TABS, 11 HEIGHT
• 00840996136143: TOMCAT,0P GUIDE,TABS, 10 HEIGHT
• 00840996136136: TOMCAT,0P GUIDE,TABS, 9 HEIGHT
• 00840996136129: TOMCAT,0P GUIDE,TABS, 8 HEIGHT
• 00840996136112: TOMCAT,0P GUIDE,TABS, 7 HEIGHT
• 00840996136105: TOMCAT,0P GUIDE,TABS, 6 HEIGHT
• 00840996128803: TOMCAT,TRIAL,16X14X8,12,NO STOPS
• 00840996128797: TOMCAT,TRIAL,16X14X8,11,NO STOPS
• 00840996128780: TOMCAT,TRIAL,16X14X8,10,NO STOPS
• 00840996128773: TOMCAT,TRIAL,16X14X8,9,NO STOPS
• 00840996128766: TOMCAT,TRIAL,16X14X8,8,NO STOPS
• 00840996128759: TOMCAT,TRIAL,16X14X8,7,NO STOPS
• 00840996128742: TOMCAT,TRIAL,16X14X8,6,NO STOPS
• 00840996128735: TOMCAT,TRIAL,16X14X7,12,NO STOPS
• 00840996128728: TOMCAT,TRIAL,16X14X7,11,NO STOPS
• 00840996128711: TOMCAT,TRIAL,16X14X7,10,NO STOPS
• 00840996128704: TOMCAT,TRIAL,16X14X7,9,NO STOPS
• 00840996128698: TOMCAT,TRIAL,16X14X7,8,NO STOPS
• 00840996128681: TOMCAT,TRIAL,16X14X7,7,NO STOPS
• 00840996128674: TOMCAT,TRIAL,16X14X7,6,NO STOPS
• 00840996128667: TOMCAT,TRIAL,16X14X5,12,NO STOPS
• 00840996128650: TOMCAT,TRIAL,16X14X5,11,NO STOPS
• 00840996128643: TOMCAT,TRIAL,16X14X5,10,NO STOPS
• 00840996128636: TOMCAT,TRIAL,16X14X5,9,NO STOPS
• 00840996128629: TOMCAT,TRIAL,16X14X5,8,NO STOPS
• 00840996128612: TOMCAT,TRIAL,16X14X5,7,NO STOPS
• 00840996128605: TOMCAT,TRIAL,16X14X5,6,NO STOPS
• 00840996128599: TOMCAT,TRIAL,16X14X4,12,NO STOPS
• 00840996128582: TOMCAT,TRIAL,16X14X4,11,NO STOPS
• 00840996128575: TOMCAT,TRIAL,16X14X4,10,NO STOPS
• 00840996128568: TOMCAT,TRIAL,16X14X4,9,NO STOPS
• 00840996128551: TOMCAT,TRIAL,16X14X4,8,NO STOPS
• 00840996128544: TOMCAT,TRIAL,16X14X4,7,NO STOPS
• 00840996128537: TOMCAT,TRIAL,16X14X4,6,NO STOPS