FCD-2 IMPLANT SYSTEM 9063-00

GUDID 00857360007190

FCD-2 Implant System, ANCHOR

DECIMA SPINE, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00857360007190
• NIH Device Record Key: ffa73873-4f70-42f5-96c7-e4d431f8a1aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FCD-2 IMPLANT SYSTEM
• Version Model Number: 9063
• Catalog Number: 9063-00
• Company DUNS: 080963983
• Company Name: DECIMA SPINE, INC.
• 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: true
• 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 (954) 243-6103
• Email: carlos@decimaspine.com
• Phone: +1 (954) 243-6103
• Email: carlos@decimaspine.com
• Phone: +1 (954) 243-6103
• Email: carlos@decimaspine.com
• Phone: +1 (954) 243-6103
• Email: carlos@decimaspine.com
• Phone: +1 (954) 243-6103
• Email: carlos@decimaspine.com
• Phone: +1 (954) 243-6103
• Email: carlos@decimaspine.com
• Phone: +1 (954) 243-6103
• Email: carlos@decimaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857360007190 [Primary]

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-05-09
• Device Publish Date: 2018-04-08

On-Brand Devices [FCD-2 IMPLANT SYSTEM]

• 00857360007190: FCD-2 Implant System, ANCHOR
• 00857360007176: FCD-2 Implant System, Stabilizer