ALTIVO Anterior Cervical Fixation System

GUDID B030FCP2319E0

1-1, 19mm plate, extended

CAMBER SPINE TECHNOLOGIES, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B030FCP2319E0
• NIH Device Record Key: a1b7a074-73f1-4e54-9935-7ab7ca642bd7
• Commercial Distribution Discontinuation: 2023-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ALTIVO Anterior Cervical Fixation System
• Version Model Number: FCP-2319E
• Company DUNS: 054205979
• Company Name: CAMBER SPINE TECHNOLOGIES, LLC
• 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: 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 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com
• Phone: +1 (484) 427-7060
• Email: quality@cambermedtech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030FCP2319E0 [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

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

[B030FCP2319E0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2022-11-01

On-Brand Devices [ALTIVO Anterior Cervical Fixation System]

• B030FCP5030020: 2-2 Assembly Block Lid, FORTICO System
• B030FCP5020020: 2-2 Assembly Block Base, FORTICO System
• B030FCP412E0: 2-2, 17mm plate, extended, 12mm spacer
• B030FCP411E0: 2-2, 16mm plate, extended, 11mm spacer
• B030FCP410E0: 2-2, 15mm plate, extended, 10mm spacer
• B030FCP409E0: 2-2, 14mm plate, extended, 9mm spacer
• B030FCP408E0: 2-2, 13mm plate, extended, 8mm spacer
• B030FCP407E0: 2-2, 12mm plate, extended, 7mm spacer
• B030FCP406E0: 2-2, 11mm plate, extended, 6mm spacer
• B030FCP405E0: 2-2, 10mm plate, extended, 5mm spacer
• B030FCP3065M0: Ø3.0, center screw, 6.5mm
• B030FCP3045M0: Ø3.0, center screw, 4.5mm
• B030FCP2546E0: 2-2, 46mm plate, extended
• B030FCP2545E0: 2-2, 45mm plate, extended
• B030FCP2544E0: 2-2, 44mm plate, extended
• B030FCP2543E0: 2-2, 43mm plate, extended
• B030FCP2542E0: 2-2, 42mm plate, extended
• B030FCP2541E0: 2-2, 41mm plate, extended
• B030FCP2540E0: 2-2, 40mm plate, extended
• B030FCP2539E0: 2-2, 39mm plate, extended
• B030FCP2538E0: 2-2, 38mm plate, extended
• B030FCP2537E0: 2-2, 37mm plate, extended
• B030FCP2536E0: 2-2, 36mm plate, extended
• B030FCP2535E0: 2-2, 35mm plate, extended
• B030FCP2534E0: 2-2, 34mm plate, extended
• B030FCP2533E0: 2-2, 33mm plate, extended
• B030FCP2532E0: 2-2, 32mm plate, extended
• B030FCP2531E0: 2-2, 31mm plate, extended
• B030FCP2530E0: 2-2, 30mm plate, extended
• B030FCP2529E0: 2-2, 29mm plate, extended
• B030FCP2528E0: 2-2, 28mm plate, extended
• B030FCP2527E0: 2-2, 27mm plate, extended
• B030FCP2526E0: 2-2, 26mm plate, extended
• B030FCP2525E0: 2-2, 25mm plate, extended
• B030FCP2524E0: 2-2, 24mm plate, extended
• B030FCP2523E0: 2-2, 23mm plate, extended
• B030FCP2522E0: 2-2, 22mm plate, extended
• B030FCP2521E0: 2-2, 21mm plate, extended
• B030FCP2520E0: 2-2, 20mm plate, extended
• B030FCP2519E0: 2-2, 19mm plate, extended
• B030FCP2446E0: 2-1, 46mm plate, extended
• B030FCP2445E0: 2-1, 45mm plate, extended
• B030FCP2444E0: 2-1, 44mm plate, extended
• B030FCP2443E0: 2-1, 43mm plate, extended
• B030FCP2442E0: 2-1, 42mm plate, extended
• B030FCP2441E0: 2-1, 41mm plate, extended
• B030FCP2440E0: 2-1, 40mm plate, extended
• B030FCP2439E0: 2-1, 39mm plate, extended
• B030FCP2438E0: 2-1, 38mm plate, extended
• B030FCP2437E0: 2-1, 37mm plate, extended