FORTICO Anterior Cervical Fixation System

GUDID B030FCP23350

1-1, 35mm plate, standard

CAMBER SPINE TECHNOLOGIES, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B030FCP23350
• NIH Device Record Key: 9b736fbe-b1f8-4bb7-831c-ad11516a204c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORTICO Anterior Cervical Fixation System
• Version Model Number: FCP-2335
• Company DUNS: 054205979
• Company Name: CAMBER SPINE TECHNOLOGIES, LLC
• 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: 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: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com
• Phone: 18666430739
• Email: customerservice@cambermedtech.com

Device Dimensions

• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter
• Length: 35 Millimeter
• Width: 16 Millimeter
• Depth: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030FCP23350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191584

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

[B030FCP23350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-02
• Device Publish Date: 2020-08-25

On-Brand Devices [FORTICO Anterior Cervical Fixation System]

• B030FCP2120: 1-1, 17mm plate, standard, 12mm spacer
• B030FCP2110: 1-1, 16mm plate, standard, 11mm spacer
• B030FCP2100: 1-1, 15mm plate, standard, 10mm spacer
• B030FCP2090: 1-1, 14mm plate, standard, 9mm spacer
• B030FCP2080: 1-1, 13mm plate, standard, 8mm spacer
• B030FCP2070: 1-1, 12mm plate, standard, 7mm spacer
• B030FCP2060: 1-1, 11mm plate, standard, 6mm spacer
• B030FCP2050: 1-1, 10mm plate, standard, 5mm spacer
• B030FCP23210: 1-1, 21mm plate, standard
• B030FCP23200: 1-1, 20mm plate, standard
• B030FCP23190: 1-1, 19mm plate, standard
• B030FCP3120: 2-1, 17mm plate, standard, 12mm spacer
• B030FCP3110: 2-1, 16mm plate, standard, 11mm spacer
• B030FCP3100: 2-1, 15mm plate, standard, 10mm spacer
• B030FCP3090: 2-1, 14mm plate, standard, 9mm spacer
• B030FCP3080: 2-1, 13mm plate, standard, 8mm spacer
• B030FCP3070: 2-1, 12mm plate, standard, 7mm spacer
• B030FCP3060: 2-1, 11mm plate, standard, 6mm spacer
• B030FCP3050: 2-1, 10mm plate, standard, 5mm spacer
• B030FCP24190: 2-1, 19mm plate, standard
• B030FCP23460: 1-1, 46mm plate, standard
• B030FCP23450: 1-1, 45mm plate, standard
• B030FCP23440: 1-1, 44mm plate, standard
• B030FCP23430: 1-1, 43mm plate, standard
• B030FCP23420: 1-1, 42mm plate, standard
• B030FCP23410: 1-1, 41mm plate, standard
• B030FCP23400: 1-1, 40mm plate, standard
• B030FCP23390: 1-1, 39mm plate, standard
• B030FCP23380: 1-1, 38mm plate, standard
• B030FCP23370: 1-1, 37mm plate, standard
• B030FCP23360: 1-1, 36mm plate, standard
• B030FCP23350: 1-1, 35mm plate, standard
• B030FCP23340: 1-1, 34mm plate, standard
• B030FCP23330: 1-1, 33mm plate, standard
• B030FCP23320: 1-1, 32mm plate, standard
• B030FCP23310: 1-1, 31mm plate, standard
• B030FCP23300: 1-1, 30mm plate, standard
• B030FCP23290: 1-1, 29mm plate, standard
• B030FCP23280: 1-1, 28mm plate, standard
• B030FCP23270: 1-1, 27mm plate, standard
• B030FCP23260: 1-1, 26mm plate, standard
• B030FCP23250: 1-1, 25mm plate, standard
• B030FCP23240: 1-1, 24mm plate, standard
• B030FCP23230: 1-1, 23mm plate, standard
• B030FCP23220: 1-1, 22mm plate, standard
• B030FCP4050: 2-2, 10mm plate, standard, 5mm spacer
• B030FCP24460: 2-1, 46mm plate, standard
• B030FCP24450: 2-1, 45mm plate, standard
• B030FCP24440: 2-1, 44mm plate, standard
• B030FCP24430: 2-1, 43mm plate, standard