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FDA 510(k), K182182, YUKON OCT Spinal System
FDA 510(k), K182182, YUKON OCT Spinal System
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$149.00 USD
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510(K) Number: K182182
Device Name: YUKON OCT Spinal System
Manufacturer: Nancy Giezen
Device Classification Name: Posterior Cervical Screw System
Regulation Number: NKG
Classification Product Code: 08/13/2018
Date Received: 11/15/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: YUKON OCT Spinal System
Manufacturer: Nancy Giezen
Device Classification Name: Posterior Cervical Screw System
Regulation Number: NKG
Classification Product Code: 08/13/2018
Date Received: 11/15/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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