Cleared Special

Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem

K193050 · Zimmer GmbH · Orthopedic

Dec 2019

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K193050 is an FDA 510(k) clearance for the Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on December 26, 2019, 55 days after receiving the submission on November 1, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K193050 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2019
Decision Date	December 26, 2019
Days to Decision	55 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

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