TYPHOON™Facet Screw Fixation System

GUDID 00840996146661

SPCL,TYPHOON,DRILL,SHORT, 4.5DIA

Choice Spine, LP

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00840996146661
• NIH Device Record Key: 8e8127dc-3fc5-4118-9eef-26dacce1b648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TYPHOON™Facet Screw Fixation System
• Version Model Number: SPCL-K003
• 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	00840996146661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121850

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996146661]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-21

On-Brand Devices [TYPHOON™Facet Screw Fixation System]

• 00840996146661: SPCL,TYPHOON,DRILL,SHORT, 4.5DIA
• 00840996146654: SPCL,TYPHOON,DRILL GUIDE,SHORT
• 00840996146647: SPCL,TYPHOON,DRILL GUIDE
• 00840996131414: TYPHOON,TAP,5.5,ADJUSTABLE,SOLID
• 00840996131407: TYPHOON,TAP,4.0,ADJUSTABLE,SOLID
• 00840996131391: TYPHOON,DRILL,FIXED,SOLID,5.5X40
• 00840996131384: TYPHOON,DRILL,FIXED,SOLID,5.5X35
• 00840996131377: TYPHOON,DRILL,FIXED,SOLID,5.5X30
• 00840996131360: TYPHOON,DRILL,FIXED,SOLID,5.5X25
• 00840996131353: TYPHOON,DRILL,FIXED,SOLID,4.5X40
• 00840996131346: TYPHOON,DRILL,FIXED,SOLID,4.5X35
• 00840996131339: TYPHOON,DRILL,FIXED,SOLID,4.5X30
• 00840996131322: TYPHOON,DRILL,FIXED,SOLID,4.5X25
• 00840996131315: TYPHOON,DRILL,FIXED,SOLID,4.5X23
• 00840996131308: FACET,4.5,FIXED,SOLID,4.5X22
• 00840996131292: TYPHOON,DRILL,FIXED,SOLID,4.5X21
• 00840996131285: TYPHOON,DRILL,FIXED,SOLID,4.5X20
• 00840996131278: TYPHOON,DRILL,FIXED,SOLID,3.0X40
• 00840996131261: TYPHOON,DRILL,FIXED,SOLID,3.0X35
• 00840996131254: TYPHOON,DRILL,FIXED,SOLID,3.0X30
• 00840996131247: TYPHOON,DRILL,FIXED,SOLID,3.0X25
• 00840996131230: TYPHOON,DRILL,FIXED,SOLID,3.0X23
• 00840996131223: TYPHOON,DRILL,FIXED,SOLID,3.0X21
• 00840996131216: TYPHOON,DRILL,FIXED,SOLID,3.0X20
• 00840996131209: TYPHOON,WASHER PLACEMENT DEV
• 00840996131193: TYPHOON,WASHER HOLDER
• 00840996131186: TYPHOON,DT GUIDE
• 00840996131179: TYPHOON,TAP,5.5,CALIBRATED,SOLID
• 00840996131162: TYPHOON,TAP,4.5,CALIBRATED,SOLID
• 00840996131155: TYPHOON,TAP,4.0,CALIBRATED,SOLID
• 00840996131148: TYPHOON,DRILL,5.5,ADJUSTABLE,SOLID
• 00840996131131: TYPHOON,DRILL,5.5,ADJUSTABLE,SOLID
• 00840996131124: TYPHOON,DRILL,4.5,ADJUSTABLE,SOLID
• 00840996131117: TYPHOON,DRILL,4.5,ADJUSTABLE,SOLID
• 00840996131100: TYPHOON,MI,TAP,5.5,ADJUSTABLE,CANN
• 00840996131094: TYPHOON,MI,TAP,4.5,ADJUSTABLE,CANN
• 00840996131087: TYPHOON,MI,DRILL,5.5,ADJUSTABLE,CANN
• 00840996131070: TYPHOON,MI,DRILL,4.5,ADJUSTABLE,CANN
• 00840996131063: TYPHOON,MI,INITIAL DILATOR
• 00840996131056: TYPHOON,MI,GUIDEWIRE SLEEVE
• 00840996131049: TYPHOON,MI,SLAP HAMMER
• 00840996131032: TYPHOON,MI,FINAL DILATOR
• 00840996131025: TYPHOON,MI,DRIVER SLEEVE,WIDE
• 00840996131018: TYPHOON,MI,DRIVER,CANNULATED
• 00840996131001: TYPHOON,MI,DT GUIDE/DILATOR,HANDLE
• 00840996130998: TYPHOON,MI,DT GUIDE/DILATOR,BODY
• 00840996130981: TYPHOON,MI,IMPACTING CAP
• 00840996130974: TYPHOON,MI,AWL,SOLID
• 00840996130967: FACET,HANDLE,AO,TORQUE,7.5 IN-LB
• 00840996130950: FACET,HANDLE,AO,TORQUE,10 IN-LB