THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System

GUDID 00840996135108

5.5 DEFORM,HOOK,OFFSET LEFT,LARGE,9.6

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

• Primary Device ID: 00840996135108
• NIH Device Record Key: a0ebb434-f2ff-430c-829b-9f3e8dddb0a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System
• Version Model Number: MT80-DLL96
• 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: 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	00840996135108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160775

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

Moist Heat or Steam Sterilization

[00840996135108]

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: 2016-07-02

On-Brand Devices [THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System]

• 00840996135504: 5.5 DEFORM,COUNTERTORQUE
• 00840996135498: 5.5 DEFORM,HOOK PUSHER
• 00840996135481: 5.5 DEFORM,HOOK IMPACTOR
• 00840996135474: 5.5 DEFORM,SLOT INSERTER
• 00840996135467: 5.5 DEFORM,STRAIGHT INSERTER
• 00840996135450: 5.5 DEFORM,ANGLED INSERTER
• 00840996135443: 5.5 DEFORM,SIDE INSERTER
• 00840996135436: 5.5 DEFORM,HOOK STARTER,PEDICLE
• 00840996135429: 5.5 DEFORM,HOOK STARTER,LAMINA
• 00840996135412: 5.5 DEFORM,HOOK STARTER,TRANSVERSE
• 00840996135405: UNIV,T HANDLE,TORQUE,100,LARGE HUDSON
• 00840996135399: 5.5 DEFORM,HOOK,INFRA LAMINAR,SMALL,6.0
• 00840996135382: 5.5 DEFORM,HOOK,INFRA LAMINAR,MEDIUM,8.0
• 00840996135375: 5.5 DEFORM,HOOK,INFRA LAMINAR,LARGE,9.6
• 00840996135368: 5.5 DEFORM,HOOK,TRANSVERSE,SMALL,6.0
• 00840996135351: 5.5 DEFORM,HOOK,TRANSVERSE,MEDIUM,8.0
• 00840996135344: 5.5 DEFORM,HOOK,TRANSVERSE,LARGE,9.6
• 00840996135337: 5.5 DEFORM,HOOK,SUPRA LAMINAR,SMALL,6.0
• 00840996135320: 5.5 DEFORM,HOOK,SUPRA LAMINAR,MEDIUM,8.0
• 00840996135313: 5.5 DEFORM,HOOK,SUPRA LAMINAR,LARGE,9.6
• 00840996135306: 5.5 DEFORM,HOOK,PEDICLE,SMALL,5.2
• 00840996135290: 5.5 DEFORM,HOOK,PEDICLE,MEDIUM,6.5
• 00840996135283: 5.5 DEFORM,HOOK,PEDICLE,LARGE,7.5
• 00840996135276: 5.5 DEFORM,HOOK,LAMINA,SMALL,6.0
• 00840996135269: 5.5 DEFORM,HOOK,LAMINA,MEDIUM,8.0
• 00840996135252: 5.5 DEFORM,HOOK,LAMINA,LARGE,9.6
• 00840996135245: 5.5 DEFORM,HOOK,FLUSH RIGHT,SMALL,6.0
• 00840996135238: 5.5 DEFORM,HOOK,FLUSH RIGHT,MEDIUM,8.0
• 00840996135221: 5.5 DEFORM,HOOK,FLUSH RIGHT,LARGE,9.6
• 00840996135214: 5.5 DEFORM,HOOK,FLUSH LEFT,SMALL,6.0
• 00840996135207: 5.5 DEFORM,HOOK,FLUSH LEFT,MEDIUM,8.0
• 00840996135191: 5.5 DEFORM,HOOK,FLUSH LEFT,LARGE,9.6
• 00840996135184: 5.5 DEFORM,HOOK,EXT LAMINA,SMALL,6.0
• 00840996135177: 5.5 DEFORM,HOOK,EXT LAMINA,MEDIUM,8.0
• 00840996135160: 5.5 DEFORM,HOOK,EXT LAMINA,LARGE,9.6
• 00840996135153: 5.5 DEFORM,HOOK,OFFSET RIGHT,SMALL,6.0
• 00840996135146: 5.5 DEFORM,HOOK,OFFSET RIGHT,MEDIUM,8.0
• 00840996135139: 5.5 DEFORM,HOOK,OFFSET RIGHT,LARGE,9.6
• 00840996135122: 5.5 DEFORM,HOOK,OFFSET LEFT,SMALL,6.0
• 00840996135115: 5.5 DEFORM,HOOK,OFFSET LEFT,MEDIUM,8.0
• 00840996135108: 5.5 DEFORM,HOOK,OFFSET LEFT,LARGE,9.6
• 00840996135092: 5.5 DEFORM,HOOK,ANGLED RIGHT,SMALL,5.5
• 00840996135085: 5.5 DEFORM,HOOK,ANGLED RIGHT,MEDIUM,6.5
• 00840996135078: 5.5 DEFORM,HOOK,ANGLED RIGHT,LARGE,7.5
• 00840996134279: 5.5 DEFORM,HOOK,ANGLED LEFT,SMALL,5.5
• 00840996134262: 5.5 DEFORM,HOOK,ANGLED LEFT,MEDIUM,6.5
• 00840996134255: 5.5 DEFORM,HOOK,ANGLED LEFT,LARGE,7.5