ROSA Knee System
K-Number: K182964 · 2019-01-24
ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2019-01-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ROSA Knee System is a medical device manufactured by Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2019-01-24 under approval number K182964. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ROSA Knee System?
ROSA Knee System is a medical device that received FDA 510(k) clearance on 2019-01-24. It is manufactured by Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K182964.
When was ROSA Knee System approved by the FDA?
ROSA Knee System received FDA 510(k) clearance on 2019-01-24, under approval number K182964.
What company makes ROSA Knee System?
ROSA Knee System is manufactured by Orthosoft Inc (D/B/A Zimmer Cas).
What is the FDA product code for ROSA Knee System?
The FDA product code for ROSA Knee System is OLO.
Other Devices by Orthosoft Inc (D/B/A Zimmer Cas)
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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.