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FDA 510(k), K193559, NextAR TKA Platform
FDA 510(k), K193559, NextAR TKA Platform
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510(K) Number: K193559
Device Name: NextAR TKA Platform
Manufacturer: Stefano Baj
Device Classification Name: Orthopaedic Surgical Planning And Instrument Guides
Regulation Number: PBF
Classification Product Code: 12/23/2019
Date Received: 07/10/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: NextAR TKA Platform
Manufacturer: Stefano Baj
Device Classification Name: Orthopaedic Surgical Planning And Instrument Guides
Regulation Number: PBF
Classification Product Code: 12/23/2019
Date Received: 07/10/2020
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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