Medtronic Navigation, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 1 Recalls: 3

Known Identifiers & Locations

FEI Numbers 1000517638
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K081512 STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE 2008-07-18 Substantially Equivalent View Details

FDA Recall History (3)

Recall # Product Description Initiation Date Status Action
Z-0001-2012 Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. Reason: Distal end of tactile probe may break off during use. 2011-01-20 Terminated View Details
Z-0002-2012 Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. Reason: Distal end of tactile probe may break off during use. 2011-01-20 Terminated View Details
Z-0025-2018 VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip Reason: The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process. 2017-07-27 Terminated View Details

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