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

FDA 510(k)

KMTI Hip Replacement System

K-Number: K203472 · 2021-04-02

ApplicantKyocera Medical Technologies, Inc.
Decision Date2021-04-02
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KMTI Hip Replacement System is a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-04-02 under approval number K203472. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KMTI Hip Replacement System?

KMTI Hip Replacement System is a medical device that received FDA 510(k) clearance on 2021-04-02. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K203472.

When was KMTI Hip Replacement System approved by the FDA?

KMTI Hip Replacement System received FDA 510(k) clearance on 2021-04-02, under approval number K203472.

What company makes KMTI Hip Replacement System?

KMTI Hip Replacement System is manufactured by Kyocera Medical Technologies, Inc..

What is the FDA product code for KMTI Hip Replacement System?

The FDA product code for KMTI Hip Replacement System is OQG.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING

Other Devices by Kyocera Medical Technologies, Inc.

K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K200709Kyocera Bipolar Hip 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 K223105Tesera-K SC System

View all 15 devices →

Related Devices (Code: OQG)

K172651FMP Extended LinersEncore Medical L.P. K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc. K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.

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.

↑