UNIKO PointCloud Knee Instruments
K-Number: K240327 · 2024-06-27
ApplicantUnik Orthopedics, Inc.
Decision Date2024-06-27
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
UNIKO PointCloud Knee Instruments is a medical device manufactured by Unik Orthopedics, Inc.. It received FDA 510(k) clearance on 2024-06-27 under approval number K240327. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UNIKO PointCloud Knee Instruments?
UNIKO PointCloud Knee Instruments is a medical device that received FDA 510(k) clearance on 2024-06-27. It is manufactured by Unik Orthopedics, Inc.. The 510(k) number is K240327.
When was UNIKO PointCloud Knee Instruments approved by the FDA?
UNIKO PointCloud Knee Instruments received FDA 510(k) clearance on 2024-06-27, under approval number K240327.
What company makes UNIKO PointCloud Knee Instruments?
UNIKO PointCloud Knee Instruments is manufactured by Unik Orthopedics, Inc..
What is the FDA product code for UNIKO PointCloud Knee Instruments?
The FDA product code for UNIKO PointCloud Knee Instruments is JWH.
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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.