THUNDERBOLT

GUDID 00840996190305

THUNDERBOLT,X-TAB SCREW,6.0X40X080

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996190305
• NIH Device Record Key: 0430995d-5592-4981-8b6c-4f1afcdd5175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBOLT
• Version Model Number: MT11-6040-080
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996190305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171456

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

[00840996190305]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [THUNDERBOLT]

• 00840996193085: THUNDERBOLT,HT THREAD,DRIVER,NVL
• 00840996192712: 70 IN-LB TRQ HDL,T,LG HUDSON,MEDTORQUE
• 00840996192705: CANN AXIAL RATCHET HDL,QTR SQ,MEDTORQUE
• 00840996192699: THUNDERBOLT,X-TAB,SET SCREW FINAL DRIVER
• 00840996192682: TBOLT,X-TAB,COUNTERTORQUE,LONG
• 00840996192675: TBOLT,X-TAB,COUNTERTORQUE,SHORT
• 00840996192668: TBOLT,X-TAB,TULIP POSITIONER
• 00840996192651: TBOLT,X-TAB,SET SCREW STARTER
• 00840996192644: TBOLT,X-TAB,INT ARTICULATING ROD INSRTR
• 00840996192637: TBOLT,X-TAB,INT ROD INSERTER,INNER SHAFT
• 00840996192620: TBOLT,X-TAB,INT ROD INSERTER,OUTER SHAFT
• 00840996192613: THUNDERBOLT,X-TAB,OPEN TAB ALIGHNER
• 00840996192606: THUNDERBOLT,X-TAB,TAB BREAKER
• 00840996192590: THUNDERBOLT,X-TAB,MODULAR TAB STABILIZER
• 00840996192583: THUNDERBOLT,K-WIRE GUIDE
• 00840996192576: THUNDERBOLT,JAMSHIDI GUIDE
• 00840996192361: THUNDERBOLT,X-TAB SCREW,10.5X110X120
• 00840996192354: THUNDERBOLT,X-TAB SCREW,10.5X100X120
• 00840996192347: THUNDERBOLT,X-TAB SCREW,10.5X90X120
• 00840996192330: THUNDERBOLT,X-TAB SCREW,10.5X80X120
• 00840996192323: THUNDERBOLT,X-TAB SCREW,10.5X75X120
• 00840996192316: THUNDERBOLT,X-TAB SCREW,10.5X70X120
• 00840996192309: THUNDERBOLT,X-TAB SCREW,10.5X65X120
• 00840996192293: THUNDERBOLT,X-TAB SCREW,10.5X60X120
• 00840996192286: THUNDERBOLT,X-TAB SCREW,10.5X55X120
• 00840996192279: THUNDERBOLT,X-TAB SCREW,10.5X50X120
• 00840996192262: THUNDERBOLT,X-TAB SCREW,10.5X45X120
• 00840996192255: THUNDERBOLT,X-TAB SCREW,10.5X40X120
• 00840996192248: THUNDERBOLT,X-TAB SCREW,10.5X35X120
• 00840996192231: THUNDERBOLT,X-TAB SCREW,10.5X30X120
• 00840996192224: THUNDERBOLT,X-TAB SCREW,10.5X25X120
• 00840996192217: THUNDERBOLT,X-TAB SCREW,10.5X110X080
• 00840996192200: THUNDERBOLT,X-TAB SCREW,10.5X100X080
• 00840996192194: THUNDERBOLT,X-TAB SCREW,10.5X90X080
• 00840996192187: THUNDERBOLT,X-TAB SCREW,10.5X80X080
• 00840996192170: THUNDERBOLT,X-TAB SCREW,10.5X75X080
• 00840996192163: THUNDERBOLT,X-TAB SCREW,10.5X70X080
• 00840996192156: THUNDERBOLT,X-TAB SCREW,10.5X65X080
• 00840996192149: THUNDERBOLT,X-TAB SCREW,10.5X60X080
• 00840996192132: THUNDERBOLT,X-TAB SCREW,10.5X55X080
• 00840996192125: THUNDERBOLT,X-TAB SCREW,10.5X50X080
• 00840996192118: THUNDERBOLT,X-TAB SCREW,10.5X45X080
• 00840996192101: THUNDERBOLT,X-TAB SCREW,10.5X40X080
• 00840996192095: THUNDERBOLT,X-TAB SCREW,10.5X35X080
• 00840996192088: THUNDERBOLT,X-TAB SCREW,10.5X30X080
• 00840996192071: THUNDERBOLT,X-TAB SCREW,10.5X25X080
• 00840996192064: THUNDERBOLT,X-TAB SCREW,9.5X110X120
• 00840996192057: THUNDERBOLT,X-TAB SCREW,9.5X100X120
• 00840996192040: THUNDERBOLT,X-TAB SCREW,9.5X90X120
• 00840996192033: THUNDERBOLT,X-TAB SCREW,9.5X80X120