SPIRA®-O Open Matrix OLIF

GUDID B030SPO1030010

Articulating Inserter Handle

CAMBER SPINE TECHNOLOGIES, LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: B030SPO1030010
• NIH Device Record Key: ce06d26a-9d3b-44e2-ba6a-61c5d56d1651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRA®-O Open Matrix OLIF
• Version Model Number: SPO-103-001
• Company DUNS: 054205979
• Company Name: CAMBER SPINE TECHNOLOGIES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030SPO1030010 [Primary]

FDA Product Code

• GAD: Retractor

Sterilization

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

[B030SPO1030010]

Moist Heat or Steam Sterilization

[B030SPO1030010]

Moist Heat or Steam Sterilization

[B030SPO1030010]

Moist Heat or Steam Sterilization

[B030SPO1030010]

Moist Heat or Steam Sterilization

[B030SPO1030010]

Moist Heat or Steam Sterilization

[B030SPO1030010]

Moist Heat or Steam Sterilization

[B030SPO1030010]

Moist Heat or Steam Sterilization

[B030SPO1030010]

Moist Heat or Steam Sterilization

[B030SPO1030010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2022-11-01

On-Brand Devices [SPIRA®-O Open Matrix OLIF]

• B030SPO1030010: Articulating Inserter Handle
• B030SPL1031010: Articulating Inserter Handle, Lateral