Cleared Traditional

CoCr Head

K211047 · Zimmer GmbH · Orthopedic

Jan 2023

Decision

642d

Days

Class 2

Risk

About This 510(k) Submission

K211047 is an FDA 510(k) clearance for the CoCr Head, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on January 10, 2023, 642 days after receiving the submission on April 8, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K211047 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2021
Decision Date	January 10, 2023
Days to Decision	642 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358