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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 the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2019-08-28 under 510(k) 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. The listed applicant is Implantcast GmbH. The 510(k) number is K191569.

When did Implantcast ic-Bipolar Head System receive FDA 510(k) clearance?

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

Who is the listed applicant for Implantcast ic-Bipolar Head System?

The FDA 510(k) record lists Implantcast GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Implantcast GmbH as applicant

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Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical 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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