Cleared Special

Libertas Acetabular Hooded Liner

K183365 · Maxx Orthopedics, Inc. · Orthopedic

Feb 2019

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K183365 is an FDA 510(k) clearance for the Libertas Acetabular Hooded Liner, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on February 22, 2019, 80 days after receiving the submission on December 4, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K183365 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2018
Decision Date	February 22, 2019
Days to Decision	80 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353