LANCER™/THUNDERBOLT™ Pedicle Screw System

GUDID 00840996127554

LANCER,STARTER,SINGLE,SET SCREW

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996127554
• NIH Device Record Key: 0757da37-739e-4d51-a1f4-36c1c726bd5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LANCER™/THUNDERBOLT™ Pedicle Screw System
• Version Model Number: M070-0037
• 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	00840996127554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132049

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996127554]

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: 2016-02-26

On-Brand Devices [LANCER™/THUNDERBOLT™ Pedicle Screw System]

• 00840996146944: SPCL,T HANDLE,TORQUE,100,QTR SQUARE
• 00840996146937: SPCL,THUNDERBOLT,KWIRE,.056x24
• 00840996146920: SPCL,THUNDERBOLT,KWIRE,.056x20
• 00840996146913: SPCL,LANCER,SCREWDRIVER,SOLID SLEEVE
• 00840996146906: SPCL,LANCER, EXTENDED ROD ROCKER
• 00840996146890: SPCL UNIV,PROBE,BALL-TIP,GRADUATED
• 00840996146883: SPCL,LANCER,7.5 TAP,KNURLED
• 00840996146876: SPCL,LANCER,6.5 TAP,KNURLED
• 00840996146869: SPCL,LANCER,5.5 TAP,KNURLED
• 00840996146852: SPCL,LANCER,7.5 TAP,KNURLED,BUI
• 00840996146845: SPCL,LANCER,6.5 TAP,KNURLED,BUI
• 00840996146838: SPCL,LANCER,5.5 TAP,KNURLED,BUI
• 00840996146821: SPCL,LANCER,TULIP POSITIONER
• 00840996146814: SPCL,LANCER,REDUCER T-HANDLE
• 00840996146807: SPCL,LANCER,COUNTERTORQUE,BAILEY
• 00840996146791: SPCL,LANCER,LEVER REDUCER
• 00840996146784: SPCL,LANCER,SCISSOR ROCKER
• 00840996146777: SPCL,LANCER,TULIP POSITIONER
• 00840996146180: LANCER,TAP,5.0
• 00840996146173: THUNDERBOLT,ARTICULATING ROD INSERTER
• 00840996146166: TBOLT,ROD,PREBENT,CO,5.5X200
• 00840996146159: TBOLT,ROD,PREBENT,CO,5.5X195
• 00840996146142: TBOLT,ROD,PREBENT,CO,5.5X190
• 00840996146135: TBOLT,ROD,PREBENT,CO,5.5X185
• 00840996146128: TBOLT,ROD,PREBENT,CO,5.5X180
• 00840996146111: TBOLT,ROD,PREBENT,CO,5.5X175
• 00840996146104: TBOLT,ROD,PREBENT,CO,5.5X170
• 00840996146098: TBOLT,ROD,PREBENT,CO,5.5X165
• 00840996146081: TBOLT,ROD,PREBENT,CO,5.5X160
• 00840996146074: TBOLT,ROD,PREBENT,CO,5.5X155
• 00840996146067: TBOLT,ROD,PREBENT,CO,5.5X150
• 00840996146050: TBOLT,ROD,PREBENT,CO,5.5X145
• 00840996146043: TBOLT,ROD,PREBENT,CO,5.5X140
• 00840996146036: TBOLT,ROD,PREBENT,CO,5.5X135
• 00840996136211: TBOLT,NAVIGATION TAP,7.5
• 00840996136204: TBOLT,NAVIGATION TAP,6.5
• 00840996136198: TBOLT,NAVIGATION TAP,5.5
• 00840996136181: TBOLT,NAVIGATION TAP,4.5
• 00840996136174: THUNDERBOLT,NAVIGATION CONNECTOR
• 00840996136075: THUNDERBOLT,MI ROD INSERTER
• 00840996135917: SPECIAL,TBOLT,T-HANDLE SET SCREW STARTER
• 00840996135818: THUNDERBOLT,KWIRE,SS,TROCAR-TROCAR,24"
• 00840996135801: THUNDERBOLT,KWIRE,SS,TROCAR-TROCAR,22"
• 00840996135795: THUNDERBOLT,KWIRE,SS,TROCAR-TROCAR,20"
• 00840996135788: THUNDERBOLT,KWIRE,SS,TROCAR-TROCAR,12"
• 00840996135771: THUNDERBOLT,KWIRE,SS,BLUNT-TROCAR,24"
• 00840996135764: THUNDERBOLT,KWIRE,SS,BLUNT-TROCAR,22"
• 00840996135757: THUNDERBOLT,KWIRE,SS,BLUNT-TROCAR,20"
• 00840996135740: THUNDERBOLT,KWIRE,SS,BLUNT-TROCAR,12"
• 00840996135733: THUNDERBOLT,KWIRE,SS,BLUNT-BLUNT,24"