ROSA® Knee System
K-Number: K213708 · 2022-04-22
ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2022-04-22
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 2022-04-22 under approval number K213708. 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 2022-04-22. It is manufactured by Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K213708.
When was ROSA® Knee System approved by the FDA?
ROSA® Knee System received FDA 510(k) clearance on 2022-04-22, under approval number K213708.
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.