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FDA 510(k)

Implantcast ic-Bipolar Head System

K-Number: K191569 · 2019-08-28

ApplicantImplantcast GmbH
Decision Date2019-08-28
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Implantcast ic-Bipolar Head System is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2019-08-28 under approval number K191569. 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 Implantcast ic-Bipolar Head System?

Implantcast ic-Bipolar Head System is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Implantcast GmbH. The 510(k) number is K191569.

When was Implantcast ic-Bipolar Head System approved by the FDA?

Implantcast ic-Bipolar Head System received FDA 510(k) clearance on 2019-08-28, under approval number K191569.

What company makes Implantcast ic-Bipolar Head System?

Implantcast ic-Bipolar Head System is manufactured by Implantcast GmbH.

What is the FDA product code for Implantcast ic-Bipolar Head System?

The FDA product code for Implantcast ic-Bipolar Head System is KWY.

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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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