SPIRA®-O Open Matrix OLIF

GUDID B030SPL1031010

Articulating Inserter Handle, Lateral

CAMBER SPINE TECHNOLOGIES, LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: B030SPL1031010
• NIH Device Record Key: 0fa26e28-0f3b-449f-8add-65869052d916
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRA®-O Open Matrix OLIF
• Version Model Number: SPL-103-101
• 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	B030SPL1031010 [Primary]

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

[B030SPL1031010]

Moist Heat or Steam Sterilization

[B030SPL1031010]

Moist Heat or Steam Sterilization

[B030SPL1031010]

Moist Heat or Steam Sterilization

[B030SPL1031010]

Moist Heat or Steam Sterilization

[B030SPL1031010]

Moist Heat or Steam Sterilization

[B030SPL1031010]

Moist Heat or Steam Sterilization

[B030SPL1031010]

Moist Heat or Steam Sterilization

[B030SPL1031010]

Moist Heat or Steam Sterilization

[B030SPL1031010]

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