ORTHROS

GUDID B030CC50002020

Instrument Tray 1 Level 2

CAMBER SPINE TECHNOLOGIES, LLC

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: B030CC50002020
• NIH Device Record Key: 757951d3-32d0-45c7-8235-dcf0e879604c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHROS
• Version Model Number: CC-500-02-02
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030CC50002020 [Primary]

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

[B030CC50002020]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-13
• Device Publish Date: 2023-11-03

On-Brand Devices [ORTHROS]

• B030ORT8595R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 95mm Lg.
• B030ORT8595CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 95mm Lg.
• B030ORT8595C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 95mm Lg.
• B030ORT85950: Ø8.5mm Polyaxial Pedicle Screw, 95mm Lg.
• B030ORT8590R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 90mm Lg.
• B030ORT8590CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 90mm Lg.
• B030ORT8590C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 90mm Lg.
• B030ORT85900: Ø8.5mm Polyaxial Pedicle Screw, 90mm Lg.
• B030ORT8585R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 85mm Lg.
• B030ORT8585CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 85mm Lg.
• B030ORT8585C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 85mm Lg.
• B030ORT85850: Ø8.5mm Polyaxial Pedicle Screw, 85mm Lg.
• B030ORT8580R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 80mm Lg.
• B030ORT8580CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 80mm Lg.
• B030ORT8580C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 80mm Lg.
• B030ORT85800: Ø8.5mm Polyaxial Pedicle Screw, 80mm Lg.
• B030ORT8575R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 75mm Lg.
• B030ORT8575CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 75mm Lg.
• B030ORT8575C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 75mm Lg.
• B030ORT85750: Ø8.5mm Polyaxial Pedicle Screw, 75mm Lg.
• B030ORT8570R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 70mm Lg.
• B030ORT8570CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 70mm Lg.
• B030ORT8570C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 70mm Lg.
• B030ORT85700: Ø8.5mm Polyaxial Pedicle Screw, 70mm Lg.
• B030ORT8565R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 65mm Lg.
• B030ORT8565CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 65mm Lg.
• B030ORT8565C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 65mm Lg.
• B030ORT85650: Ø8.5mm Polyaxial Pedicle Screw, 65mm Lg.
• B030ORT8560R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 60mm Lg.
• B030ORT8560CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 60mm Lg.
• B030ORT8560C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 60mm Lg.
• B030ORT85600: Ø8.5mm Polyaxial Pedicle Screw, 60mm Lg.
• B030ORT8555R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 55mm Lg.
• B030ORT8555CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 55mm Lg.
• B030ORT8555C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 55mm Lg.
• B030ORT85550: Ø8.5mm Polyaxial Pedicle Screw, 55mm Lg.
• B030ORT8550R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 50mm Lg.
• B030ORT8550CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 50mm Lg.
• B030ORT8550C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 50mm Lg.
• B030ORT85500: Ø8.5mm Polyaxial Pedicle Screw, 50mm Lg.
• B030ORT8545R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 45mm Lg.
• B030ORT8545CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 45mm Lg.
• B030ORT8545C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 45mm Lg.
• B030ORT85450: Ø8.5mm Polyaxial Pedicle Screw, 45mm Lg.
• B030ORT8540R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 40mm Lg.
• B030ORT8540CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 40mm Lg.
• B030ORT8540C0: Ø8.5mm Cannulated Polyaxial Pedicle Screw, 40mm Lg.
• B030ORT85400: Ø8.5mm Polyaxial Pedicle Screw, 40mm Lg.
• B030ORT8535R0: Ø8.5mm Polyaxial Reduction Pedicle Screw, 35mm Lg.
• B030ORT8535CR0: Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 35mm Lg.