Alcantara Thoracolumbar Plating NA

GUDID B030SAZ5540FD0

5.5mm, Fixed Angle, Self-Drilling Bone Screw, 40mm

CAMBER SPINE TECHNOLOGIES, LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: B030SAZ5540FD0
• NIH Device Record Key: 227b28b6-d781-4bbe-8f7f-cc0e8e3d8c51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcantara Thoracolumbar Plating
• Version Model Number: SAZ-5540FD
• Catalog Number: NA
• 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
• 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	B030SAZ5540FD0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232256

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

[B030SAZ5540FD0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-25
• Device Publish Date: 2024-07-17

On-Brand Devices [Alcantara Thoracolumbar Plating]

• B030TLP424WL0: 4-hole Windswept Sacral Plate, Left, 36mm
• B030TLP422WL0: 4-hole Windswept Sacral Plate, Left, 34mm
• B030TLP420WL0: 4-hole Windswept Sacral Plate, Left, 32mm
• B030SAZ5545FD0: 5.5mm, Fixed Angle, Self-Drilling Bone Screw, 45mm
• B030SAZ5540FD0: 5.5mm, Fixed Angle, Self-Drilling Bone Screw, 40mm