FDA 510(k)

UNIKO PointCloud Knee Instruments

K-Number: K193312 · 2020-08-12

Decision Date2020-08-12

Product CodeMBH

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 2020-08-12 under approval number K193312. The device is classified under product code MBH. 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 2020-08-12. It is manufactured by Unik Orthopedics, Inc.. The 510(k) number is K193312.

When was UNIKO PointCloud Knee Instruments approved by the FDA?

UNIKO PointCloud Knee Instruments received FDA 510(k) clearance on 2020-08-12, under approval number K193312.

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 MBH.

Other Devices by Unik Orthopedics, Inc.

K240327UNIKO PointCloud Knee Instruments

Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.