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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 a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-10 under approval 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. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K242045.

When was Initia T3 Acetabular Hemispherical Shell System approved by the FDA?

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

What company makes Initia T3 Acetabular Hemispherical Shell System?

Initia T3 Acetabular Hemispherical Shell System is manufactured by Kyocera Medical Technologies, Inc..

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.

Related Clinical Trials

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Other Devices by Kyocera Medical Technologies, Inc.

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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