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FDA 510(k), K171269, X-PSI Knee System
FDA 510(k), K171269, X-PSI Knee System
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510(K) Number: K171269
Device Name: X-PSI Knee System
Manufacturer: Orthosoft Inc. (d/b/a Zimmer CAS)
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 05/01/2017
Decision Date: 12/28/2017
Regulation Medical Specialty: Orthopedic
Device Name: X-PSI Knee System
Manufacturer: Orthosoft Inc. (d/b/a Zimmer CAS)
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 05/01/2017
Decision Date: 12/28/2017
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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