Orthros CC-004-55

GUDID B030CC004550

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B030CC004550
• NIH Device Record Key: cb4e174b-83bf-4367-93b1-29f2559e30a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthros
• Version Model Number: Ø8.5mm Polyaxial Pedicle Screw, 110mm Lg.
• Catalog Number: CC-004-55
• Company DUNS: 054205979
• Company Name: CAMBER SPINE TECHNOLOGIES, LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030CC004550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133366

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

[B030CC004550]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-05
• Device Publish Date: 2015-10-26

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.