SpineSmith IN:C2 Spinal Fixation System 1100-0002-PL

GUDID 00817771027637

IN:C2 Cervical System Kit

Celling Biosciences

Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00817771027637
• NIH Device Record Key: a987559b-d5f4-4989-95ce-c5f22e523f30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineSmith IN:C2 Spinal Fixation System
• Version Model Number: 1100-0002-PL
• Catalog Number: 1100-0002-PL
• Company DUNS: 021560394
• Company Name: Celling Biosciences
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-206-0770
• Email: CustomerService@CellingBiosciences.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817771027637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122630

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

[00817771027637]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-02-14

On-Brand Devices [SpineSmith IN:C2 Spinal Fixation System]

• 00817771029822: IN:C2 Cervical System Kit w/stopless Trials
• 00817771029815: IN:C2 Cervical System Kit w/Stopless Trials
• 00817771027637: IN:C2 Cervical System Kit