iASSIST Knee System
K-Number: K213033 · 2022-01-14
ApplicantOrthosoft D/B/A Zimmer Cas
Decision Date2022-01-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
iASSIST Knee System is a medical device manufactured by Orthosoft D/B/A Zimmer Cas. It received FDA 510(k) clearance on 2022-01-14 under approval number K213033. 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 iASSIST Knee System?
iASSIST Knee System is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Orthosoft D/B/A Zimmer Cas. The 510(k) number is K213033.
When was iASSIST Knee System approved by the FDA?
iASSIST Knee System received FDA 510(k) clearance on 2022-01-14, under approval number K213033.
What company makes iASSIST Knee System?
iASSIST Knee System is manufactured by Orthosoft D/B/A Zimmer Cas.
What is the FDA product code for iASSIST Knee System?
The FDA product code for iASSIST Knee System is OLO.
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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.