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Parker Quality & Compliance

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510(k) clearance

Momentum Acetabular Cup System

FDA 510(k) source

510(k) number
K253948
Applicant
United Orthopedic Corporation
Decision date
Sep 2, 2026
Date received
Dec 10, 2025
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
LZO
Device type
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class
Class II
Regulation
21 CFR 888.3353
Advisory committee
Orthopedic
Statement or summary
Summary
Third party
N
Location
Kaohsiung City, TW