Alcantara™ Thoracolumbar Plating

GUDID B030TLP428WR0

4-Hole Right Windswept Sacral Plate, 40mm

CAMBER SPINE TECHNOLOGIES, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B030TLP428WR0
• NIH Device Record Key: f67907d7-400d-465e-b441-1f4662157430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcantara™ Thoracolumbar Plating
• Version Model Number: TLP-428WR
• 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: false
• 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	B030TLP428WR0 [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

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

[B030TLP428WR0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [Alcantara™ Thoracolumbar Plating]

• B030TLP440WR0: 4-Hole Right Windswept Sacral Plate, 54mm
• B030TLP438WR0: 4-Hole Right Windswept Sacral Plate, 52mm
• B030TLP436WR0: 4-Hole Right Windswept Sacral Plate, 49mm
• B030TLP434WR0: 4-Hole Right Windswept Sacral Plate, 47mm
• B030TLP432WR0: 4-Hole Right Windswept Sacral Plate, 46mm
• B030TLP430WR0: 4-Hole Right Windswept Sacral Plate, 42mm
• B030TLP428WR0: 4-Hole Right Windswept Sacral Plate, 40mm
• B030TLP426WR0: 4-Hole Right Windswept Sacral Plate, 38mm
• B030TLP424WR0: 4-Hole Right Windswept Sacral Plate, 36mm
• B030TLP422WR0: 4-Hole Right Windswept Sacral Plate, 34mm
• B030TLP420WR0: 4-Hole Right Windswept Sacral Plate, 32mm