TOMCAT Cervical Spinal System

GUDID 00840996160148

TOMCAT,STERILE,HYBRID,HA,16X14X8,11

Choice Spine, LP

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00840996160148
• NIH Device Record Key: 76376a81-dad3-40e7-ac76-6ce6478e27fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOMCAT Cervical Spinal System
• Version Model Number: S-RH30-1614811
• 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: true
• 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

Device Dimensions

• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996160148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170953

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-28

On-Brand Devices [TOMCAT Cervical Spinal System]

• 00840996176385: Tomcat, Driver, Angled, U-Joint
• 00840996175692: TOMCAT,DRILL GUIDE,OFFSET
• 00840996175685: TOMCAT,OP GUIDE,PLUGS,12 HEIGHT
• 00840996175678: TOMCAT,OP GUIDE,PLUGS,11 HEIGHT
• 00840996175661: TOMCAT,OP GUIDE,PLUGS,10 HEIGHT
• 00840996175654: TOMCAT,OP GUIDE,PLUGS,9 HEIGHT
• 00840996175647: TOMCAT,OP GUIDE,PLUGS,8 HEIGHT
• 00840996175630: TOMCAT,OP GUIDE,PLUGS,7 HEIGHT
• 00840996175623: TOMCAT,OP GUIDE,PLUGS,6 HEIGHT
• 00840996173919: TOMCAT,AWL,SPRING LOADED
• 00840996163897: TOMCAT,FIXED ANGLE DRILL, 14D
• 00840996163880: TOMCAT,FIXED ANGLE DRILL, 12D
• 00840996163873: TOMCAT,0P GUIDE,PLUG, 12 HEIGHT
• 00840996163866: TOMCAT,0P GUIDE,PLUG, 11 HEIGHT
• 00840996163859: TOMCAT,0P GUIDE,PLUG, 10 HEIGHT
• 00840996163842: TOMCAT,0P GUIDE,PLUG, 9 HEIGHT
• 00840996163835: TOMCAT,0P GUIDE,PLUG, 8 HEIGHT
• 00840996163828: TOMCAT,0P GUIDE,PLUG, 7 HEIGHT
• 00840996163811: TOMCAT,0P GUIDE,PLUG, 6 HEIGHT
• 00840996163705: TOMCAT,THREADED SCREWDRIVER
• 00840996161428: TOMCAT,DRIVER,ANGLED,SHORT
• 00840996150330: TOMCAT,AWL,ANGLED,LONG
• 00840996150149: TOMCAT,U-JOINT,FORCEPS
• 00840996150132: TOMCAT,U-JOINT DRIVER,SPLIT TIP W/COLLAR
• 00840996160292: TOMCAT,STERILE,HYBRID,HA,16X18X8,12
• 00840996160285: TOMCAT,STERILE,HYBRID,HA,16X18X8,11
• 00840996160278: TOMCAT,STERILE,HYBRID,HA,16X18X8,10
• 00840996160261: TOMCAT,STERILE,HYBRID,HA,16X18X8,9
• 00840996160254: TOMCAT,STERILE,HYBRID,HA,16X18X8,8
• 00840996160247: TOMCAT,STERILE,HYBRID,HA,16X18X8,7
• 00840996160230: TOMCAT,STERILE,HYBRID,HA,16X18X8,6
• 00840996160223: TOMCAT,STERILE,HYBRID,HA,16X16X8,12
• 00840996160216: TOMCAT,STERILE,HYBRID,HA,16X16X8,11
• 00840996160209: TOMCAT,STERILE,HYBRID,HA,16X16X8,10
• 00840996160193: TOMCAT,STERILE,HYBRID,HA,16X16X8,9
• 00840996160186: TOMCAT,STERILE,HYBRID,HA,16X16X8,8
• 00840996160179: TOMCAT,STERILE,HYBRID,HA,16X16X8,7
• 00840996160162: TOMCAT,STERILE,HYBRID,HA,16X16X8,6
• 00840996160155: TOMCAT,STERILE,HYBRID,HA,16X14X8,12
• 00840996160148: TOMCAT,STERILE,HYBRID,HA,16X14X8,11
• 00840996160131: TOMCAT,STERILE,HYBRID,HA,16X14X8,10
• 00840996160124: TOMCAT,STERILE,HYBRID,HA,16X14X8,9
• 00840996160117: TOMCAT,STERILE,HYBRID,HA,16X14X8,8
• 00840996160100: TOMCAT,STERILE,HYBRID,HA,16X14X8,7
• 00840996160094: TOMCAT,STERILE,HYBRID,HA,16X14X8,6
• 00840996160087: TOMCAT,STERILE,HYBRID,HA,14X12X8,12
• 00840996160070: TOMCAT,STERILE,HYBRID,HA,14X12X8,11
• 00840996160063: TOMCAT,STERILE,HYBRID,HA,14X12X8,10
• 00840996160056: TOMCAT,STERILE,HYBRID,HA,14X12X8,9
• 00840996160049: TOMCAT,STERILE,HYBRID,HA,14X12X8,8