Orthros MIS

GUDID B030ORM75950

Ø7.5mm MIS Polyaxial Pedicle Screw, 95mm

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B030ORM75950
• NIH Device Record Key: ca79cb13-747b-42a7-a630-f47d43a600f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthros MIS
• Version Model Number: ORM-7595
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com

Device Dimensions

• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030ORM75950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180980

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

[B030ORM75950]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-05
• Device Publish Date: 2019-02-01

On-Brand Devices [Orthros MIS]

• B030ORM95C0: Ø5.5mm Curved Rod 95mm Lg.
• B030ORM90C0: Ø5.5mm Curved Rod 90mm Lg.
• B030ORM85C0: Ø5.5mm Curved Rod 85mm Lg.
• B030ORM8595L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 95mm Lg. Long Tower
• B030ORM85950: Ø8.5mm MIS Polyaxial Pedicle Screw, 95mm
• B030ORM8590L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 90mm Lg. Long Tower
• B030ORM85900: Ø8.5mm MIS Polyaxial Pedicle Screw, 90mm
• B030ORM8585L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 85mm Lg. Long Tower
• B030ORM85850: Ø8.5mm MIS Polyaxial Pedicle Screw, 85mm
• B030ORM8580L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 80mm Lg. Long Tower
• B030ORM85800: Ø8.5mm MIS Polyaxial Pedicle Screw, 80mm
• B030ORM8575L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 75mm Lg. Long Tower
• B030ORM85750: Ø8.5mm MIS Polyaxial Pedicle Screw, 75mm
• B030ORM8570L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 70mm Lg. Long Tower
• B030ORM85700: Ø8.5mm MIS Polyaxial Pedicle Screw, 70mm
• B030ORM8565L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 65mm Lg. Long Tower
• B030ORM85650: Ø8.5mm MIS Polyaxial Pedicle Screw, 65mm
• B030ORM8560L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 60mm Lg. Long Tower
• B030ORM85600: Ø8.5mm MIS Polyaxial Pedicle Screw, 60mm
• B030ORM8555L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 55mm Lg. Long Tower
• B030ORM85550: Ø8.5mm MIS Polyaxial Pedicle Screw, 55mm
• B030ORM8550L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 50mm Lg. Long Tower
• B030ORM85500: Ø8.5mm MIS Polyaxial Pedicle Screw, 50mm
• B030ORM8545L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 45mm Lg. Long Tower
• B030ORM85450: Ø8.5mm MIS Polyaxial Pedicle Screw, 45mm
• B030ORM8540L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 40mm Lg. Long Tower
• B030ORM85400: Ø8.5mm MIS Polyaxial Pedicle Screw, 40mm
• B030ORM8535L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 35mm Lg. Long Tower
• B030ORM85350: Ø8.5mm MIS Polyaxial Pedicle Screw, 35mm
• B030ORM8530L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 30mm Lg. Long Tower
• B030ORM85300: Ø8.5mm MIS Polyaxial Pedicle Screw, 30mm
• B030ORM85110L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 110mm Lg. Long Tower
• B030ORM851100: Ø8.5mm MIS Polyaxial Pedicle Screw, 110mm
• B030ORM85105L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 105mm Lg. Long Tower
• B030ORM851050: Ø8.5mm MIS Polyaxial Pedicle Screw, 105mm
• B030ORM85100L0: Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 100mm Lg. Long Tower
• B030ORM851000: Ø8.5mm MIS Polyaxial Pedicle Screw, 100mm
• B030ORM80C0: Ø5.5mm Curved Rod 80mm Lg.
• B030ORM75C0: Ø5.5mm Curved Rod 75mm Lg.
• B030ORM7595L0: Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 95mm Lg. Long Tower
• B030ORM75950: Ø7.5mm MIS Polyaxial Pedicle Screw, 95mm
• B030ORM7590L0: Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 90mm Lg. Long Tower
• B030ORM75900: Ø7.5mm MIS Polyaxial Pedicle Screw, 90mm
• B030ORM7585L0: Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 85mm Lg. Long Tower
• B030ORM75850: Ø7.5mm MIS Polyaxial Pedicle Screw, 85mm
• B030ORM7580L0: Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 80mm Lg. Long Tower
• B030ORM75800: Ø7.5mm MIS Polyaxial Pedicle Screw, 80mm
• B030ORM7575L0: Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 75mm Lg. Long Tower
• B030ORM75750: Ø7.5mm MIS Polyaxial Pedicle Screw, 75mm
• B030ORM7570L0: Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 70mm Lg. Long Tower