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FDA 510(k)

iNSitu Bipolar Hip System

K-Number: K191297 · 2019-09-17

ApplicantTheken Companies, LLC
Decision Date2019-09-17
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

iNSitu Bipolar Hip System is a medical device manufactured by Theken Companies, LLC. It received FDA 510(k) clearance on 2019-09-17 under approval number K191297. 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 iNSitu Bipolar Hip System?

iNSitu Bipolar Hip System is a medical device that received FDA 510(k) clearance on 2019-09-17. It is manufactured by Theken Companies, LLC. The 510(k) number is K191297.

When was iNSitu Bipolar Hip System approved by the FDA?

iNSitu Bipolar Hip System received FDA 510(k) clearance on 2019-09-17, under approval number K191297.

What company makes iNSitu Bipolar Hip System?

iNSitu Bipolar Hip System is manufactured by Theken Companies, LLC.

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

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

Related Clinical Trials

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Other Devices by Theken Companies, LLC

K161184iNSitu Total Hip System K172501iNSitu Total Hip System K192071iNSitu Total Hip System

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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