Orthors

GUDID B030ORT5535C0

Ø5.5mm Cannulated Polyaxial Pedicle Screw, 35mm Lg.

CAMBER SPINE TECHNOLOGIES, LLC

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

• Primary Device ID: B030ORT5535C0
• NIH Device Record Key: dbdf3e92-34bc-46a2-8d3b-8c479a425482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthors
• Version Model Number: ORT-5535C
• 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

Device Dimensions

• Length: 35 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030ORT5535C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133366

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[B030ORT5535C0]

Moist Heat or Steam Sterilization

[B030ORT5535C0]

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: 2019-01-18

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