SCS CLARIS Spinal System

GUDID 00840996163668

SCS,DRIVER,FINAL TIGHTENING

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996163668
• NIH Device Record Key: 64710fd0-aacb-4f7f-b86d-eb546850f30a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCS CLARIS Spinal System
• Version Model Number: 1070-1012
• 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
• 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	00840996163668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021379

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

Moist Heat or Steam Sterilization

[00840996163668]

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: 2017-09-13

On-Brand Devices [SCS CLARIS Spinal System]

• 00840996174695: UNIV,T HANDLE, TORQUE,90,SQUARE
• 00840996174404: UNIV,ROD BENDER,FRENCH
• 00840996163675: SCS,DRIVER SHAFT,POLYAXIAL
• 00840996163668: SCS,DRIVER,FINAL TIGHTENING
• 00840996122924: CLARIS,CONNECTOR,OMNIAXIAL,EXTEND,LONG
• 00840996122917: CLARIS,CONNECTOR,OMNIAXIAL,EXTEND,MED
• 00840996122894: CLARIS,CONNECTOR,LATERAL,LONG,M6
• 00840996122887: CLARIS,CONNECTOR,LATERAL,EXTREMITY,M6
• 00840996122870: CLARIS,CONNECTOR,LATERAL,EXTREMITY
• 00840996122863: CLARIS,CONNECTOR,LATERAL,LONG,EXTREMITY
• 00840996122856: CLARIS,CONNECTOR,LATERAL