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FDA 510(k)

Kyocera Bipolar Hip System

K-Number: K200709 · 2020-04-17

ApplicantKyocera Medical Technologies, Inc.
Decision Date2020-04-17
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kyocera Bipolar Hip System is a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-04-17 under approval number K200709. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kyocera Bipolar Hip System?

Kyocera Bipolar Hip System is a medical device that received FDA 510(k) clearance on 2020-04-17. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K200709.

When was Kyocera Bipolar Hip System approved by the FDA?

Kyocera Bipolar Hip System received FDA 510(k) clearance on 2020-04-17, under approval number K200709.

What company makes Kyocera Bipolar Hip System?

Kyocera Bipolar Hip System is manufactured by Kyocera Medical Technologies, Inc..

What is the FDA product code for Kyocera Bipolar Hip System?

The FDA product code for Kyocera Bipolar Hip System is KWY.

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Other Devices by Kyocera Medical Technologies, Inc.

K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System K212070KMTI S141 Lumbar Interbody Fusion System K203472KMTI Hip Replacement System K223105Tesera-K SC System

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Related Devices (Code: KWY)

K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation K170072Fitmore® Hip StemZimmer GmbH K173455SurgTech Bipolar Head SystemSurgtech, Inc. K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc. K16308140-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd. K192236Fitmore Hip StemZimmer GmbH

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.

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