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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Libertas Acetabular Liners (Acetabular Liner)

FDA 510(k) source

510(k) number
K260975
Applicant
Maxx Orthopedics, Inc.
Decision date
Oct 29, 2026
Date received
Mar 24, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
JDI
Device type
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class
Class II
Regulation
21 CFR 888.3350
Advisory committee
Orthopedic
Statement or summary
Summary
Third party
N
Location
Norristown, PA, US