ORTHROS Posterior Stabilization System

GUDID B030CP004021

Ø6.5mm Polyaxial Pedicle Screw, 65mm Lg.

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B030CP004021
• NIH Device Record Key: 47d5f874-76a2-450a-8ccf-f878ac51c0c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHROS Posterior Stabilization System
• Version Model Number: CP-004-21
• 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
• 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	B030CP004021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133366

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

[B030CP004021]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

Devices Manufactured by CAMBER SPINE TECHNOLOGIES, LLC

• B0301000501400 - TLS 5.0: 2023-11-13 T-Handle, QC, 1/4" Square Adapter
• B030CC117410 - ORTHROS: 2023-11-13 Threaded Polyaxial Screwdriver, T25
• 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