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FDA 510(k)

UNIKO PointCloud™ Knee Instruments

K-Number: K193312 · 2020-08-12

ApplicantUnik Orthopedics, Inc.
Decision Date2020-08-12
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIKO PointCloud™ Knee Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Unik Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-08-12 under 510(k) 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. The listed applicant is Unik Orthopedics, Inc.. The 510(k) number is K193312.

When did UNIKO PointCloud™ Knee Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for UNIKO PointCloud™ Knee Instruments?

The FDA 510(k) record lists Unik Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIKO PointCloud™ Knee Instruments?

The FDA product code for UNIKO PointCloud™ Knee Instruments is MBH.

Other records listing Unik Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240327UNIKO PointCloud™ Knee Instruments

Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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.

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