FDA 510(k), K180690, Navigation Instruments

FDA 510(k), K180690, Navigation Instruments

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510(K) Number: K180690
Device Name: Navigation Instruments
Manufacturer: Globus Medical Inc.
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 03/16/2018
Decision Date: 06/25/2018
Regulation Medical Specialty: Neurology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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