SPIRA®-C Open Matrix Cervical Interbody

GUDID B030SPC131812090

13mm x 18mm, 12° Lordotic, 9mm

CAMBER SPINE TECHNOLOGIES, LLC

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• Primary Device ID: B030SPC131812090
• NIH Device Record Key: 21ad5683-bbc3-403b-ba2e-d27e283a32d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRA®-C Open Matrix Cervical Interbody
• Version Model Number: SPC-1318-1209
• 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	B030SPC131812090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172446

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B030SPC131812090]

Moist Heat or Steam Sterilization

[B030SPC131812090]

Moist Heat or Steam Sterilization

[B030SPC131812090]

Moist Heat or Steam Sterilization

[B030SPC131812090]

Moist Heat or Steam Sterilization

[B030SPC131812090]

Moist Heat or Steam Sterilization

[B030SPC131812090]

Moist Heat or Steam Sterilization

[B030SPC131812090]

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

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• B030CC117520 - ORTHROS: 2023-11-13 T30 Final Tightening Driver, 1/4" QC
• B030CC117530 - ORTHROS: 2023-11-13 T30 Self-Centering Screwdriver, 1/4" QC
• B030CC131320 - ORTHROS: 2023-11-13 Screw Head Positioner
• B030CC50002010 - ORTHROS: 2023-11-13 Instrument Tray 1 Level 1
• B030CC50002020 - ORTHROS: 2023-11-13 Instrument Tray 1 Level 2
• B030CC50002030 - ORTHROS: 2023-11-13 Instrument Tray 1 Shell