Alcantara Thoracolumbar Plating NA

GUDID B030SAZ5535VD0

5.5mm, Variable Angle, Self-Drilling Bone Screw, 35mm

CAMBER SPINE TECHNOLOGIES, LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: B030SAZ5535VD0
• NIH Device Record Key: 1204ee29-6444-47b8-81e4-b8297d337ef8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcantara Thoracolumbar Plating
• Version Model Number: SAZ-5535VD
• 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
• 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	B030SAZ5535VD0 [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

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

[B030SAZ5535VD0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-19

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
• B030TLP45400: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 54mm
• B030TLP45380: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 52mm
• B030TLP45360: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 49mm
• B030TLP45340: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 47mm
• B030TLP45320: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 46mm
• B030TLP45300: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 42mm
• B030TLP45280: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 40mm
• B030TLP45260: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 38mm
• B030TLP45240: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 36mm
• B030TLP45220: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 34mm
• B030TLP45200: 4-hole L5/S1 Lumbar Plate w/ Sacral Bump, 32mm
• B030TLP440WL0: 4-hole Windswept Sacral Plate, Left, 54mm
• B030TLP440W0: 4-hole Windswept Plate, 54mm
• B030TLP4400: Universal 4-hole Lumbar Plate, 54mm
• B030TLP438WL0: 4-hole Windswept Sacral Plate, Left, 52mm
• B030TLP438W0: 4-hole Windswept Plate, 52mm
• B030TLP4380: Universal 4-hole Lumbar Plate, 52mm
• B030TLP436WL0: 4-hole Windswept Sacral Plate, Left, 49mm
• B030TLP436W0: 4-hole Windswept Plate, 49mm
• B030TLP4360: Universal 4-hole Lumbar Plate, 49mm
• B030TLP434WL0: 4-hole Windswept Sacral Plate, Left, 47mm
• B030TLP434W0: 4-hole Windswept Plate, 47mm
• B030TLP4340: Universal 4-hole Lumbar Plate, 47mm
• B030TLP432WL0: 4-hole Windswept Sacral Plate, Left, 46mm
• B030TLP432W0: 4-hole Windswept Plate, 46mm
• B030TLP4320: Universal 4-hole Lumbar Plate, 46mm
• B030TLP430WL0: 4-hole Windswept Sacral Plate, Left, 42mm
• B030TLP430W0: 4-hole Windswept Plate, 42mm
• B030TLP4300: Universal 4-hole Lumbar Plate, 42mm
• B030TLP428WL0: 4-hole Windswept Sacral Plate, Left, 40mm
• B030TLP428W0: 4-hole Windswept Plate, 40mm
• B030TLP4280: Universal 4-hole Lumbar Plate, 40mm
• B030TLP426WL0: 4-hole Windswept Sacral Plate, Left, 38mm
• B030TLP426W0: 4-hole Windswept Plate, 38mm
• B030TLP4260: Universal 4-hole Lumbar Plate, 38mm
• B030TLP424W0: 4-hole Windswept Plate, 36mm
• B030TLP4240: Universal 4-hole Lumbar Plate, 36mm
• B030TLP422W0: 4-hole Windswept Plate, 34mm
• B030TLP4220: Universal 4-hole Lumbar Plate, 34mm
• B030TLP420W0: 4-hole Windswept Plate, 32mm
• B030TLP4200: Universal 4-hole Lumbar Plate, 32mm
• B030TLP418W0: 4-hole Windswept Plate, 30mm
• B030TLP4180: Universal 4-hole Lumbar Plate, 30mm
• B030TLP25260: 2-hole L5/S1 Lumbar Plate, 40mm
• B030TLP25240: 2-hole L5/S1 Lumbar Plate, 38mm