FALCON™ Anterior Cervical Plate

GUDID 00840996146388

FALCON,SPCL,SHORT VA GUIDE,SINGLE BARRE

Choice Spine, LP

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840996146388
• NIH Device Record Key: 4c76aa20-9b99-40f9-98e8-140a19c780a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FALCON™ Anterior Cervical Plate
• Version Model Number: SPCL-A017
• 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
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840996146388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091926

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

[00840996146388]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-21

On-Brand Devices [FALCON™ Anterior Cervical Plate]

• 00840996148146: SPCL,FALCON,AWL
• 00840996146470: SPCL,FALCON,TRIAL DRILL GUIDE,10MM TRIA
• 00840996146463: SPCL,FALCON,TRIAL DRILL GUIDE,9MM TRIAL
• 00840996146456: SPCL,FALCON,TRIAL DRILL GUIDE, 8MM TRIA
• 00840996146449: SPCL,FALCON,TRIAL DRILL GUIDE,7MM TRIAL
• 00840996146432: SPCL,FALCON,TRIAL DRILL GUIDE,6MM TRIAL
• 00840996146425: SPCL,FALCON,TRIAL DRILL GUIDE,5MM TRIAL
• 00840996146418: SPCL,FALCON,TRIAL DRILL GUIDE
• 00840996146401: FALCON,SPCL,TAPERED GUIDE,DOUBLE BARREL
• 00840996146395: FALCON,SPCL,DRILL,SHORT DG,12
• 00840996146388: FALCON,SPCL,SHORT VA GUIDE,SINGLE BARRE
• 00840996146371: FALCON,SPCL,SHORT VA GUIDE,DOUBLE BARRE
• 00840996146364: FALCON,SPCL,DRIVER,SPLIT TIP,SHORT
• 00840996146357: FALCON,SPCL,DRIVER,EXPANDING
• 00840996146340: SPCL,FALCON,FIXATION PIN,SCREW HOLE 2
• 00840996146333: SPCL,FALCON,FIXATION PIN,SCREW HOLE 1
• 00840996146326: SPCL,ACP,DRIVER,TAPERED,AO
• 00840996146319: SPCL,FALCON,FIXATION PIN,THREADED,HEX
• 00840996146302: SPCL,FALCON,DRILL GUIDE,FIXED
• 00840996146296: SPCL,FALCON,DRIVER,STRAIGHT,HEX
• 00840996146289: SPCL,ACP,DRIVER,TAPERED
• 00840996146272: SPCL,DRIVER,SCREW REMOVAL
• 00840996146265: SPCL,PLATE,AWL
• 00840996146258: FALCON,FIXATION PIN,THREADED
• 00840996131759: FALCON,TAP,3.0X16
• 00840996131742: FALCON,TAP,3.0X14
• 00840996131735: FALCON,TAP,3.0X12
• 00840996131728: FALCON,TAP,3.0X10
• 00840996131711: FALCON,TAP,3.0X8
• 00840996131704: FALCON,DRILL, 2.1X18
• 00840996131698: FALCON,DRILL, 2.1X16
• 00840996131681: FALCON,DRILL, 2.1X14
• 00840996131674: FALCON,DRILL, 2.1X12
• 00840996131667: FALCON,DRILL, 2.1X10
• 00840996131650: FALCON,DRILL, 2.1X8
• 00840996131643: FALCON,FIXATION PIN,THREADED,HEX,TI
• 00840996131636: FALCON,FIXATION PIN,THREADED,HEX DRIVE
• 00840996131629: FALCON,DRIVER,SPLIT TIP
• 00840996131612: FALCON,DRIVER,BALL,DETENT
• 00840996131605: FALCON,DRIVER,SCREW REMOVAL
• 00840996131599: SPCL,PIN,FIXATION,TEMPORARY
• 00840996131582: FALCON,AWL
• 00840996131575: FALCON,DRIVER,STRAIGHT,HEX
• 00840996131568: FALCON,DRILL GUIDE,VARIABLE
• 00840996131551: FALCON,DRIVER,REMOVAL,SPIRAL HEX
• 00840996131544: FALCON,SCREW REMOVAL TOOL,FREE SPINNING
• 00840996131537: FALCON,SLEEVE, SCREW REMOVAL
• 00840996131520: FALCON,AWL
• 00840996131513: UNIV,HANDLE,AXIAL,LONG,SPIN CAP
• 00840996131506: FALCON,PLATE HOLDER