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FDA 510(k), K172688, Align Radial Head System
FDA 510(k), K172688, Align Radial Head System
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510(K) Number: K172688
Device Name: Align Radial Head System
Manufacturer: Ana M. Escagedo
Device Classification Name: Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation Number: KWI
Classification Product Code: 09/06/2017
Date Received: 12/22/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Align Radial Head System
Manufacturer: Ana M. Escagedo
Device Classification Name: Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation Number: KWI
Classification Product Code: 09/06/2017
Date Received: 12/22/2017
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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