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FDA 510(k)

Initia T3 Acetabular Hemispherical Shell System

K-Number: K242045 · 2025-04-10

ApplicantKyocera Medical Technologies, Inc.
Decision Date2025-04-10
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Initia T3 Acetabular Hemispherical Shell 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 2025-04-10 under 510(k) number K242045. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Initia T3 Acetabular Hemispherical Shell System?

Initia T3 Acetabular Hemispherical Shell System is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K242045.

When did Initia T3 Acetabular Hemispherical Shell System receive FDA 510(k) clearance?

Initia T3 Acetabular Hemispherical Shell System received FDA 510(k) clearance on 2025-04-10, under 510(k) number K242045.

Who is the listed applicant for Initia T3 Acetabular Hemispherical Shell 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 Initia T3 Acetabular Hemispherical Shell System?

The FDA product code for Initia T3 Acetabular Hemispherical Shell System is LPH.

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Related Devices (Code: LPH)

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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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