Navigation Instruments 77-0012

GUDID 10889981148324

Navigation Malibu 8.0+ Screwdriver, 1/4 Square

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant driver

• Primary Device ID: 10889981148324
• NIH Device Record Key: f7bc7980-f288-4f14-bec3-aaba5defdb27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Instruments
• Version Model Number: 77-0012
• Catalog Number: 77-0012
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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: 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(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981148324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172517

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

[10889981148324]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [Navigation Instruments]

• 10889981148713: Navigation Malibu Tap, 8.0mm
• 10889981148690: Navigation Malibu Tap, 7.0mm
• 10889981148676: Navigation Malibu Tap, 6.0mm
• 10889981148652: Navigation Malibu Tap, 5.0mm
• 10889981148638: Navigation Malibu Tap, 4.0mm
• 10889981214067: MIS Cannulated Navigation Tap, 9.50mm
• 10889981214050: MIS Cannulated Navigation Tap, 9.00mm
• 10889981214043: MIS Cannulated Navigation Tap, 8.00mm
• 10889981214036: MIS Cannulated Navigation Tap, 7.00mm
• 10889981214029: MIS Cannulated Navigation Tap, 6.00mm
• 10889981214012: MIS Cannulated Navigation Tap, 5.00mm
• 10889981214005: MIS Cannulated Navigation Tap, 4.75mm
• 10889981213992: MIS Cannulated Navigation Tap, 10.50mm
• 10889981213985: MIS Cannulated Navigation Tap, 10.00mm
• 10889981212711: MIS Cannulated Navigation Tap, 8.50mm
• 10889981212704: MIS Cannulated Navigation Tap, 7.50mm
• 10889981212698: MIS Cannulated Navigation Tap, 6.50mm
• 10889981212681: MIS Cannulated Navigation Tap, 5.50mm
• 10889981212674: MIS Cannulated Navigation Tap, 4.50mm
• 10889981154721: Navigation Instrumentation Tray Lid, Universal
• 10889981154714: Navigation Instrumentation Tray, Level 2
• 10889981154707: Navigation Instrumentation Tray, Level 1
• 10889981154691: Navigation Instrumentation Tray, Base
• 10889981148324: Navigation Malibu 8.0+ Screwdriver, 1/4 Square