SPIRA®-A Integrated

GUDID B030SAZ263425190

SPIRA®-A Integrated, 26x34mm, 25° Lordotic, 19mm

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: B030SAZ263425190
• NIH Device Record Key: dba59daa-c269-466d-a8d6-23bb7631c83a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRA®-A Integrated
• Version Model Number: SAZ-2634-2519
• 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
• 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	B030SAZ263425190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234077

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

[B030SAZ263425190]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [SPIRA®-A Integrated]

• B030SAZ1021130: SPIRA®-A Integrated,Trial, 28x32mm, 20° Lordotic, 21mm
• B030SAZ1021120: SPIRA®-A Integrated,Trial, 28x32mm, 20° Lordotic, 19mm
• B030SAZ1021110: SPIRA®-A Integrated,Trial, 28x32mm, 20° Lordotic, 17mm
• B030SAZ1021100: SPIRA®-A Integrated,Trial, 28x32mm, 20° Lordotic, 15mm
• B030SAZ1021090: SPIRA®-A Integrated,Trial, 28x32mm, 20° Lordotic, 13mm
• B030SAZ1021080: SPIRA®-A Integrated,Trial, 28x32mm, 15° Lordotic, 21mm
• B030SAZ1021070: SPIRA®-A Integrated,Trial, 28x32mm, 15° Lordotic, 19mm
• B030SAZ1021060: SPIRA®-A Integrated,Trial, 28x32mm, 15° Lordotic, 17mm
• B030SAZ1021050: SPIRA®-A Integrated,Trial, 28x32mm, 15° Lordotic, 15mm
• B030SAZ1021040: SPIRA®-A Integrated,Trial, 28x32mm, 15° Lordotic, 13mm
• B030SAZ304230230: SPIRA®-A Integrated, 30x42mm, 30° Lordotic, 23mm
• B030SAZ304230210: SPIRA®-A Integrated, 30x42mm, 30° Lordotic, 21mm
• B030SAZ304225210: SPIRA®-A Integrated, 30x42mm, 25° Lordotic, 21mm
• B030SAZ304225190: SPIRA®-A Integrated, 30x42mm, 25° Lordotic, 19mm
• B030SAZ304225170: SPIRA®-A Integrated, 30x42mm, 25° Lordotic, 17mm
• B030SAZ304220210: SPIRA®-A Integrated, 30x42mm, 20° Lordotic, 21mm
• B030SAZ304220190: SPIRA®-A Integrated, 30x42mm, 20° Lordotic, 19mm
• B030SAZ304220170: SPIRA®-A Integrated, 30x42mm, 20° Lordotic, 17mm
• B030SAZ304220150: SPIRA®-A Integrated, 30x42mm, 20° Lordotic, 15mm
• B030SAZ304215210: SPIRA®-A Integrated, 30x42mm, 15° Lordotic, 21mm
• B030SAZ304215190: SPIRA®-A Integrated, 30x42mm, 15° Lordotic, 19mm
• B030SAZ304215170: SPIRA®-A Integrated, 30x42mm, 15° Lordotic, 17mm
• B030SAZ304215150: SPIRA®-A Integrated, 30x42mm, 15° Lordotic, 15mm
• B030SAZ304215130: SPIRA®-A Integrated, 30x42mm, 15° Lordotic, 13mm
• B030SAZ304215110: SPIRA®-A Integrated, 30x42mm, 15° Lordotic, 11mm
• B030SAZ304208210: SPIRA®-A Integrated, 30x42mm, 8° Lordotic, 21mm
• B030SAZ304208190: SPIRA®-A Integrated, 30x42mm, 8° Lordotic, 19mm
• B030SAZ304208170: SPIRA®-A Integrated, 30x42mm, 8° Lordotic, 17mm
• B030SAZ304208150: SPIRA®-A Integrated, 30x42mm, 8° Lordotic, 15mm
• B030SAZ304208130: SPIRA®-A Integrated, 30x42mm, 8° Lordotic, 13mm
• B030SAZ304208110: SPIRA®-A Integrated, 30x42mm, 8° Lordotic, 11mm
• B030SAZ304208090: SPIRA®-A Integrated, 30x42mm, 8° Lordotic, 9mm
• B030SAZ283830210: SPIRA®-A Integrated, 28x38mm, 30° Lordotic, 21mm
• B030SAZ283830190: SPIRA®-A Integrated, 28x38mm, 30° Lordotic, 19mm
• B030SAZ283825210: SPIRA®-A Integrated, 28x38mm, 25° Lordotic, 21mm
• B030SAZ283825190: SPIRA®-A Integrated, 28x38mm, 25° Lordotic, 19mm
• B030SAZ283825170: SPIRA®-A Integrated, 28x38mm, 25° Lordotic, 17mm
• B030SAZ283820210: SPIRA®-A Integrated, 28x38mm, 20° Lordotic, 21mm
• B030SAZ283820190: SPIRA®-A Integrated, 28x38mm, 20° Lordotic, 19mm
• B030SAZ283820170: SPIRA®-A Integrated, 28x38mm, 20° Lordotic, 17mm
• B030SAZ283820150: SPIRA®-A Integrated, 28x38mm, 20° Lordotic, 15mm
• B030SAZ283820130: SPIRA®-A Integrated, 28x38mm, 20° Lordotic, 13mm
• B030SAZ283815210: SPIRA®-A Integrated, 28x38mm, 15° Lordotic, 21mm
• B030SAZ283815190: SPIRA®-A Integrated, 28x38mm, 15° Lordotic, 19mm
• B030SAZ283815170: SPIRA®-A Integrated, 28x38mm, 15° Lordotic, 17mm
• B030SAZ283815150: SPIRA®-A Integrated, 28x38mm, 15° Lordotic, 15mm
• B030SAZ283815130: SPIRA®-A Integrated, 28x38mm, 15° Lordotic, 13mm
• B030SAZ283815110: SPIRA®-A Integrated, 28x38mm, 15° Lordotic, 11mm
• B030SAZ283808210: SPIRA®-A Integrated, 28x38mm, 8° Lordotic, 21mm
• B030SAZ283808190: SPIRA®-A Integrated, 28x38mm, 8° Lordotic, 19mm