1
/
of
0
FDA 510(k), K193559, NextAR TKA Platform
FDA 510(k), K193559, NextAR TKA Platform
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
Unit price
/
per
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: KXA
Date Received: 12/23/2019
Decision Date: 07/10/2020
Decision: 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: KXA
Date Received: 12/23/2019
Decision Date: 07/10/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Couldn't load pickup availability
- 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.
View full details