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510(k) K240046

Ethylene Oxide Sterilization Supplier Change for MPO Hips by Microport Orthopedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2024
Date Received
January 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
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