SPIRA®-P Integrated Fixation System

GUDID B030SPP341015100

34mm x 10mm, 10mm, 15° Lordotic

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: B030SPP341015100
• NIH Device Record Key: 9d4d8249-bd3a-458a-8f0d-f597f6f4a966
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRA®-P Integrated Fixation System
• Version Model Number: SPP-3410-1510
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030SPP341015100 [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

[B030SPP341015100]

Moist Heat or Steam Sterilization

[B030SPP341015100]

Moist Heat or Steam Sterilization

[B030SPP341015100]

Moist Heat or Steam Sterilization

[B030SPP341015100]

Moist Heat or Steam Sterilization

[B030SPP341015100]

Moist Heat or Steam Sterilization

[B030SPP341015100]

Moist Heat or Steam Sterilization

[B030SPP341015100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-10
• Device Publish Date: 2022-11-02

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

• B030SPP341215180: 34mm x 12mm, 18mm, 15° Lordotic
• B030SPP341215170: 34mm x 12mm, 17mm, 15° Lordotic
• B030SPP341215160: 34mm x 12mm, 16mm, 15° Lordotic
• B030SPP341215150: 34mm x 12mm, 15mm, 15° Lordotic
• B030SPP341215140: 34mm x 12mm, 14mm, 15° Lordotic
• B030SPP341215130: 34mm x 12mm, 13mm, 15° Lordotic
• B030SPP341215120: 34mm x 12mm, 12mm, 15° Lordotic
• B030SPP341215110: 34mm x 12mm, 11mm, 15° Lordotic
• B030SPP341207180: 34mm x 12mm, 18mm, 7° Lordotic
• B030SPP341207170: 34mm x 12mm, 17mm, 7° Lordotic
• B030SPP341207160: 34mm x 12mm, 16mm, 7° Lordotic
• B030SPP341207150: 34mm x 12mm, 15mm, 7° Lordotic
• B030SPP341207140: 34mm x 12mm, 14mm, 7° Lordotic
• B030SPP341207130: 34mm x 12mm, 13mm, 7° Lordotic
• B030SPP341207120: 34mm x 12mm, 12mm, 7° Lordotic
• B030SPP341207110: 34mm x 12mm, 11mm, 7° Lordotic
• B030SPP341207100: 34mm x 12mm, 10mm, 7° Lordotic
• B030SPP341015130: 34mm x 10mm, 13mm, 15° Lordotic
• B030SPP341015120: 34mm x 10mm, 12mm, 15° Lordotic
• B030SPP341015110: 34mm x 10mm, 11mm, 15° Lordotic
• B030SPP341015100: 34mm x 10mm, 10mm, 15° Lordotic
• B030SPP341007180: 34mm x 10mm, 18mm, 7° Lordotic
• B030SPP341007170: 34mm x 10mm, 17mm, 7° Lordotic
• B030SPP341007160: 34mm x 10mm, 16mm, 7° Lordotic
• B030SPP341007150: 34mm x 10mm, 15mm, 7° Lordotic
• B030SPP341007140: 34mm x 10mm, 14mm, 7° Lordotic
• B030SPP341007130: 34mm x 10mm, 13mm, 7° Lordotic
• B030SPP341007120: 34mm x 10mm, 12mm, 7° Lordotic
• B030SPP341007110: 34mm x 10mm, 11mm, 7° Lordotic
• B030SPP341007100: 34mm x 10mm, 10mm, 7° Lordotic
• B030SPP341007080: 34mm x 10mm, 8mm, 7° Lordotic
• B030SPP321215180: 32mm x 12mm, 18mm, 15° Lordotic
• B030SPP321215170: 32mm x 12mm, 17mm, 15° Lordotic
• B030SPP321215150: 32mm x 12mm, 15mm, 15° Lordotic
• B030SPP321215140: 32mm x 12mm, 14mm, 15° Lordotic
• B030SPP321215130: 32mm x 12mm, 13mm, 15° Lordotic
• B030SPP321215120: 32mm x 12mm, 12mm, 15° Lordotic
• B030SPP321215110: 32mm x 12mm, 11mm, 15° Lordotic
• B030SPP321215100: 32mm x 12mm, 10mm, 15° Lordotic
• B030SPP321207180: 32mm x 12mm, 18mm, 7° Lordotic
• B030SPP321207170: 32mm x 12mm, 17mm, 7° Lordotic
• B030SPP321207160: 32mm x 12mm, 16mm, 7° Lordotic
• B030SPP321207150: 32mm x 12mm, 15mm, 7° Lordotic
• B030SPP321207140: 32mm x 12mm, 14mm, 7° Lordotic
• B030SPP321207130: 32mm x 12mm, 13mm, 7° Lordotic
• B030SPP321207120: 32mm x 12mm, 12mm, 7° Lordotic
• B030SPP321207110: 32mm x 12mm, 11mm, 7° Lordotic
• B030SPP321207100: 32mm x 12mm, 10mm, 7° Lordotic
• B030SPP321207090: 32mm x 12mm, 9mm, 7° Lordotic
• B030SPP321207080: 32mm x 12mm, 8mm, 7° Lordotic