SPIRA®-T Integrated Fixation System

GUDID B030SPT221107100

22mm x 11mm, 10mm, 7° Lordotic

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: B030SPT221107100
• NIH Device Record Key: 99ca3b32-dde6-4754-bf96-ebbb942295fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRA®-T Integrated Fixation System
• Version Model Number: SPT-2211-0710
• 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	B030SPT221107100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210595

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

[B030SPT221107100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-11
• Device Publish Date: 2022-11-03

On-Brand Devices [SPIRA®-T Integrated Fixation System]

• B030SPT341115180: 34mm x 11mm, 18mm, 15° Lordotic
• B030SPT341115170: 34mm x 11mm, 17mm, 15° Lordotic
• B030SPT341115160: 34mm x 11mm, 16mm, 15° Lordotic
• B030SPT341115150: 34mm x 11mm, 15mm, 15° Lordotic
• B030SPT341115140: 34mm x 11mm, 14mm, 15° Lordotic
• B030SPT341115130: 34mm x 11mm, 13mm, 15° Lordotic
• B030SPT341115120: 34mm x 11mm, 12mm, 15° Lordotic
• B030SPT341107180: 34mm x 11mm, 18mm, 7° Lordotic
• B030SPT341107170: 34mm x 11mm, 17mm, 7° Lordotic
• B030SPT341107160: 34mm x 11mm, 16mm, 7° Lordotic
• B030SPT341107150: 34mm x 11mm, 15mm, 7° Lordotic
• B030SPT341107140: 34mm x 11mm, 14mm, 7° Lordotic
• B030SPT341107130: 34mm x 11mm, 13mm, 7° Lordotic
• B030SPT341107120: 34mm x 11mm, 12mm, 7° Lordotic
• B030SPT341107110: 34mm x 11mm, 11mm, 7° Lordotic
• B030SPT341107100: 34mm x 11mm, 10mm, 7° Lordotic
• B030SPT341107090: 34mm x 11mm, 9mm, 7° Lordotic
• B030SPT340915180: 34mm x 9mm, 18mm, 15° Lordotic
• B030SPT340915170: 34mm x 9mm, 17mm, 15° Lordotic
• B030SPT340915160: 34mm x 9mm, 16mm, 15° Lordotic
• B030SPT340915150: 34mm x 9mm, 15mm, 15° Lordotic
• B030SPT340915140: 34mm x 9mm, 14mm, 15° Lordotic
• B030SPT340915130: 34mm x 9mm, 13mm, 15° Lordotic
• B030SPT340915120: 34mm x 9mm, 12mm, 15° Lordotic
• B030SPT340907180: 34mm x 9mm, 18mm, 7° Lordotic
• B030SPT340907170: 34mm x 9mm, 17mm, 7° Lordotic
• B030SPT340907160: 34mm x 9mm, 16mm, 7° Lordotic
• B030SPT340907150: 34mm x 9mm, 15mm, 7° Lordotic
• B030SPT340907140: 34mm x 9mm, 14mm, 7° Lordotic
• B030SPT340907130: 34mm x 9mm, 13mm, 7° Lordotic
• B030SPT340907120: 34mm x 9mm, 12mm, 7° Lordotic
• B030SPT340907110: 34mm x 9mm, 11mm, 7° Lordotic
• B030SPT340907100: 34mm x 9mm, 10mm, 7° Lordotic
• B030SPT340907090: 34mm x 9mm, 9mm, 7° Lordotic
• B030SPT321115180: 32mm x 11mm, 18mm, 15° Lordotic
• B030SPT321115170: 32mm x 11mm, 17mm, 15° Lordotic
• B030SPT321115160: 32mm x 11mm, 16mm, 15° Lordotic
• B030SPT321115150: 32mm x 11mm, 15mm, 15° Lordotic
• B030SPT321115140: 32mm x 11mm, 14mm, 15° Lordotic
• B030SPT321115130: 32mm x 11mm, 13mm, 15° Lordotic
• B030SPT321115120: 32mm x 11mm, 12mm, 15° Lordotic
• B030SPT321107180: 32mm x 11mm, 18mm, 7° Lordotic
• B030SPT321107170: 32mm x 11mm, 17mm, 7° Lordotic
• B030SPT321107160: 32mm x 11mm, 16mm, 7° Lordotic
• B030SPT321107150: 32mm x 11mm, 15mm, 7° Lordotic
• B030SPT321107140: 32mm x 11mm, 14mm, 7° Lordotic
• B030SPT321107130: 32mm x 11mm, 13mm, 7° Lordotic
• B030SPT321107120: 32mm x 11mm, 12mm, 7° Lordotic
• B030SPT321107110: 32mm x 11mm, 11mm, 7° Lordotic
• B030SPT321107100: 32mm x 11mm, 10mm, 7° Lordotic