FDA 510(k), K203399, FITBONE(R) TAA
FDA 510(k), K203399, FITBONE(R) TAA
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510(K) Number: K203399
Device Name: FITBONE(R) TAA
Manufacturer: Hartmut Kampa
Device Classification Name: Rod, Fixation, Intramedullary And Accessories
Regulation Number: HSB
Classification Product Code: 11/19/2020
Date Received: 02/17/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: FITBONE(R) TAA
Manufacturer: Hartmut Kampa
Device Classification Name: Rod, Fixation, Intramedullary And Accessories
Regulation Number: HSB
Classification Product Code: 11/19/2020
Date Received: 02/17/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
- 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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