Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

X-PSI Knee System

K-Number: K171269 · 2017-12-28

Decision Date2017-12-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-PSI Knee System is a medical device manufactured by Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2017-12-28 under approval number K171269. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-PSI Knee System?

X-PSI Knee System is a medical device that received FDA 510(k) clearance on 2017-12-28. It is manufactured by Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K171269.

When was X-PSI Knee System approved by the FDA?

X-PSI Knee System received FDA 510(k) clearance on 2017-12-28, under approval number K171269.

What company makes X-PSI Knee System?

X-PSI Knee System is manufactured by Orthosoft Inc (D/B/A Zimmer Cas).

What is the FDA product code for X-PSI Knee System?

The FDA product code for X-PSI Knee System is JWH.

Other Devices by Orthosoft Inc (D/B/A Zimmer Cas)

View all 14 devices →

Related Devices (Code: JWH)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.