ORTHROS Quarter Turn

GUDID B030OQT65650

Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 65mm

CAMBER SPINE TECHNOLOGIES, LLC

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• Primary Device ID: B030OQT65650
• NIH Device Record Key: ed220f23-c720-4b43-8ff1-36d3f806383c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHROS Quarter Turn
• Version Model Number: OQT-6565
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030OQT65650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133366

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

[B030OQT65650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-02
• Device Publish Date: 2022-11-24

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