SCS CLARIS Spinal Screws

GUDID 00840996121699

CLARIS,SCREW,POST,7.5X35

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996121699
• NIH Device Record Key: 7b7cbc58-3a9a-4a3d-9611-8d11275a2c75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCS CLARIS Spinal Screws
• Version Model Number: 2T10E7-35
• 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

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
• 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 Dimensions

• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996121699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011807

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

Moist Heat or Steam Sterilization

[00840996121699]

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: 2015-10-24

On-Brand Devices [SCS CLARIS Spinal Screws]

• 00840996122412: SCS,CONNECTOR,LARGE
• 00840996122184: CLARIS,SCREW,POST,REDUCT,NOBRK,7.5X55
• 00840996122177: CLARIS,SCREW,POST,REDUCT,NOBRK,7.5X50
• 00840996122160: CLARIS,SCREW,POST,REDUCT,NOBRK,5.5X55
• 00840996122153: CLARIS,SCREW,POST,REDUCT,NOBRK,5.5X50
• 00840996122146: CLARIS,SCREW,POST,REDUCTION,6.5X55
• 00840996122139: CLARIS,SCREW,POST,REDUCTION,6.5X50
• 00840996122122: CLARIS,SCREW,POST,REDUCTION,6.5X45
• 00840996122115: CLARIS,SCREW,POST,REDUCTION,6.5X40
• 00840996122108: CLARIS,SCREW,POST,REDUCTION,6.5X35
• 00840996122092: CLARIS,SCREW,POST,8.5X55
• 00840996122085: CLARIS,SCREW,POST,8.5X50
• 00840996122078: CLARIS,SCREW,POST,8.5X45
• 00840996122061: CLARIS,SCREW,POST,8.5X40
• 00840996122054: CLARIS,SCREW,POST,7.0X50
• 00840996122047: CLARIS,SCREW,POST,7.0X45
• 00840996122030: CLARIS,SCREW,POST,7.0X40
• 00840996122023: CLARIS,SCREW,POST,7.5X55
• 00840996122016: CLARIS,SCREW,POST,7.5X50
• 00840996122009: CLARIS,SCREW,POST,7.5X45
• 00840996121996: CLARIS,SCREW,POST,7.5X40
• 00840996121989: CLARIS,SCREW,POST,7.5X35
• 00840996121972: CLARIS,SCREW,POST,7.5X30
• 00840996121965: CLARIS,SCREW,POST,7.5X25
• 00840996121958: CLARIS,SCREW,POST,6.5X55
• 00840996121941: CLARIS,SCREW,POST,6.5X50
• 00840996121934: CLARIS,SCREW,POST,6.5X45
• 00840996121927: CLARIS,SCREW,POST,6.5X40
• 00840996121910: CLARIS,SCREW,POST,6.5X35
• 00840996121903: CLARIS,SCREW,POST,6.5X30
• 00840996121897: CLARIS,SCREW,POST,5.5X55
• 00840996121880: CLARIS,SCREW,POST,5.5X50
• 00840996121873: CLARIS,SCREW,POST,5.5X45
• 00840996121866: CLARIS,SCREW,POST,5.5X40
• 00840996121859: CLARIS,SCREW,POST,5.5X35
• 00840996121842: CLARIS,SCREW,POST,5.5X30
• 00840996121835: CLARIS,SCREW,POST,9.5X55
• 00840996121828: CLARIS,SCREW,POST,9.5X50
• 00840996121811: CLARIS,SCREW,POST,9.5X45
• 00840996121804: CLARIS,SCREW,POST,9.5X40
• 00840996121798: CLARIS,SCREW,POST,9.5X35
• 00840996121781: CLARIS,SCREW,POST,8.5X55
• 00840996121774: CLARIS,SCREW,POST,8.5X50
• 00840996121767: CLARIS,SCREW,POST,8.5X45
• 00840996121750: CLARIS,SCREW,POST,8.5X40
• 00840996121743: CLARIS,SCREW,POST,8.5X35
• 00840996121736: CLARIS,SCREW,POST,7.5X55
• 00840996121729: CLARIS,SCREW,POST,7.5X50
• 00840996121712: CLARIS,SCREW,POST,7.5X45
• 00840996121705: CLARIS,SCREW,POST,7.5X40