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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 the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) 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. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K203472.

When did KMTI Hip Replacement System receive FDA 510(k) clearance?

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

Who is the listed applicant for KMTI Hip Replacement System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Kyocera Medical Technologies, Inc. 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.

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Related Devices (Code: OQG)

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.

K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport 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.K172651FMP Extended LinersEncore Medical L.P.K171543Renovis Surgical Hip Replacement SystemRenovis Surgical TechnologiesK173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint 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.

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