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FDA 510(k), K171321, K2M Navigation Instruments
FDA 510(k), K171321, K2M Navigation Instruments
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510(K) Number: K171321
Device Name: K2M Navigation Instruments
Manufacturer: Nancy Giezen
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: KXA
Date Received: 05/04/2017
Decision Date: 08/30/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: K2M Navigation Instruments
Manufacturer: Nancy Giezen
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: KXA
Date Received: 05/04/2017
Decision Date: 08/30/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- 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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