RI.KNEE Adjustable Tibia Cut Guide
K-Number: K230876 · 2023-06-27
ApplicantEnztec Limited
Decision Date2023-06-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
RI.KNEE Adjustable Tibia Cut Guide is a medical device manufactured by Enztec Limited. It received FDA 510(k) clearance on 2023-06-27 under approval number K230876. 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 RI.KNEE Adjustable Tibia Cut Guide?
RI.KNEE Adjustable Tibia Cut Guide is a medical device that received FDA 510(k) clearance on 2023-06-27. It is manufactured by Enztec Limited. The 510(k) number is K230876.
When was RI.KNEE Adjustable Tibia Cut Guide approved by the FDA?
RI.KNEE Adjustable Tibia Cut Guide received FDA 510(k) clearance on 2023-06-27, under approval number K230876.
What company makes RI.KNEE Adjustable Tibia Cut Guide?
RI.KNEE Adjustable Tibia Cut Guide is manufactured by Enztec Limited.
What is the FDA product code for RI.KNEE Adjustable Tibia Cut Guide?
The FDA product code for RI.KNEE Adjustable Tibia Cut Guide 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.