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FDA 510(k)

Ethylene Oxide Sterilization Supplier Change for MPO Hips

K-Number: K240046 · 2024-04-18

ApplicantMicroport Orthopedics
Decision Date2024-04-18
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ethylene Oxide Sterilization Supplier Change for MPO Hips is a medical device manufactured by Microport Orthopedics. It received FDA 510(k) clearance on 2024-04-18 under approval number K240046. 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 Ethylene Oxide Sterilization Supplier Change for MPO Hips?

Ethylene Oxide Sterilization Supplier Change for MPO Hips is a medical device that received FDA 510(k) clearance on 2024-04-18. It is manufactured by Microport Orthopedics. The 510(k) number is K240046.

When was Ethylene Oxide Sterilization Supplier Change for MPO Hips approved by the FDA?

Ethylene Oxide Sterilization Supplier Change for MPO Hips received FDA 510(k) clearance on 2024-04-18, under approval number K240046.

What company makes Ethylene Oxide Sterilization Supplier Change for MPO Hips?

Ethylene Oxide Sterilization Supplier Change for MPO Hips is manufactured by Microport Orthopedics.

What is the FDA product code for Ethylene Oxide Sterilization Supplier Change for MPO Hips?

The FDA product code for Ethylene Oxide Sterilization Supplier Change for MPO Hips is LPH.

Related PubMed Literature

PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025)

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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