Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Theken Companies, LLC. It received FDA 510(k) clearance on 2019-09-17 under 510(k) 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. The listed applicant is Theken Companies, LLC. The 510(k) number is K191297.

When did iNSitu Bipolar Hip System receive FDA 510(k) clearance?

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

Who is the listed applicant for iNSitu Bipolar Hip System?

The FDA 510(k) record lists Theken Companies, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Theken Companies, LLC 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.

K220336Mg-PSZ Ceramic Femoral HeadK192071iNSitu Total Hip SystemK172501iNSitu Total Hip SystemK161184iNSitu Total Hip System

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.

↑