Navigation Instrument

GUDID B030ORTNAV4501

4.5 mm Tap, Open Cannulated, Navigation

CAMBER SPINE TECHNOLOGIES, LLC

Bone tap, reusable

• Primary Device ID: B030ORTNAV4501
• NIH Device Record Key: 9d1b3b42-2326-4ec9-bb55-7e4337939565
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Instrument
• Version Model Number: ORT-NAV-4501
• 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: false
• 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
• 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	B030ORTNAV4501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220038

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

[B030ORTNAV4501]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-11
• Device Publish Date: 2022-11-03

On-Brand Devices [Navigation Instrument]

• B030ORTNAVPROBE003: Pedicle Probe, Duckbill, NAV Handle
• B030ORTNAVPROBE001: Pedicle Probe, Lenke, Straight, NAV Handle
• B030ORTNAVPEDAWL001: Pedicle Awl, Navigation
• B030ORTNAVAWL8500: 8.5 mm Awl Tap, Navigation
• B030ORTNAVAWL7500: 7.5 mm Awl Tap, Navigation
• B030ORTNAVAWL6500: 6.5 mm Awl Tap, Navigation
• B030ORTNAVAWL5500: 5.5 mm Awl Tap, Navigation
• B030ORTNAVAWL4500: 4.5 mm Awl Tap, Navigation
• B030ORTNAVAWL4000: 4.0 mm Awl Tap, Navigation
• B030ORTNAV8501: 8.5 mm Tap, Open Cannulated, Navigation
• B030ORTNAV8500: 8.5 mm Tap, Open Solid, Navigation
• B030ORTNAV7501: 7.5 mm Tap, Open Cannulated, Navigation
• B030ORTNAV7500: 7.5 mm Tap, Open Solid, Navigation
• B030ORTNAV6501: 6.5 mm Tap, Open Cannulated, Navigation
• B030ORTNAV6500: 6.5 mm Tap, Open Solid, Navigation
• B030ORTNAV5501: 5.5 mm Tap, Open Cannulated, Navigation
• B030ORTNAV5500: 5.5 mm Tap, Open Solid, Navigation
• B030ORTNAV4501: 4.5 mm Tap, Open Cannulated, Navigation
• B030ORTNAV4500: 4.5 mm Tap, Open Solid, Navigation
• B030ORTNAV4000: 4.0 mm Tap, Open Solid, Navigation
• B030ORMNAV8501: 8.5 mm Tap, MIS Solid, Navigation
• B030ORMNAV8500: 8.5 mm Tap, MIS Cannulated, Navigation
• B030ORMNAV7501: 7.5 mm Tap, MIS Solid, Navigation
• B030ORMNAV7500: 7.5 mm Tap, MIS Cannulated, Navigation
• B030ORMNAV6501: 6.5 mm Tap, MIS Solid, Navigation
• B030ORMNAV6500: 6.5 mm Tap, MIS Cannulated, Navigation
• B030ORMNAV5501: 5.5 mm Tap, MIS Solid, Navigation
• B030ORMNAV5500: 5.5 mm Tap, MIS Cannulated, Navigation
• B030ORMNAV5000: 5.0 mm Tap, MIS Cannulated, Navigation
• B030ORMNAV4501: 4.5 mm Tap, MIS Solid, Navigation
• B030NAVNEO8500: 8.5 mm Tap, NEO Solid, Navigation
• B030NAVNEO8000: 8.0 mm Tap, NEO Solid, Navigation
• B030NAVNEO7500: 7.5 mm Tap, NEO Solid, Navigation
• B030NAVNEO7000: 7.0 mm Tap, NEO Solid, Navigation
• B030NAVNEO6500: 6.5 mm Tap, NEO Solid, Navigation
• B030NAVNEO6000: 6.0 mm Tap, NEO Solid, Navigation
• B030NAVNEO5500: 5.5 mm Tap, NEO Solid, Navigation
• B030NAVNEO5000: 5.0 mm Tap, NEO Solid, Navigation
• B030NAVNEO4500: 4.5 mm Tap, NEO Solid, Navigation
• B030NAVNEO4000: 4.0 mm Tap, NEO Solid, Navigation
• B030NAVNEO11701: NEO Screwdriver, Solid, Navigation
• B030NAV50000102: Navigation Tray 2
• B030NAV50000101: Navigation Tray 1
• B030NAV1170501: QT Driver 1 of 2, Navigation
• B030NAV11704: MIS Polyaxial Cannulated Screwdriver, T25, Navigation
• B030NAV11702: MIS Polyaxial Screwdriver, T25, Navigation