OptiVu ROSA® MxR
K-Number: K230567 · 2023-06-13
ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2023-06-13
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
OptiVu ROSA® MxR is a medical device manufactured by Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2023-06-13 under approval number K230567. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OptiVu ROSA® MxR?
OptiVu ROSA® MxR is a medical device that received FDA 510(k) clearance on 2023-06-13. It is manufactured by Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K230567.
When was OptiVu ROSA® MxR approved by the FDA?
OptiVu ROSA® MxR received FDA 510(k) clearance on 2023-06-13, under approval number K230567.
What company makes OptiVu ROSA® MxR?
OptiVu ROSA® MxR is manufactured by Orthosoft Inc (D/B/A Zimmer Cas).
What is the FDA product code for OptiVu ROSA® MxR?
The FDA product code for OptiVu ROSA® MxR is SBF.
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.