Cleared Special

COPAL exchange G hip spacer

K220492 · Heraeus Medical GmbH · Orthopedic

Mar 2022

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K220492 is an FDA 510(k) clearance for the COPAL exchange G hip spacer, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on March 23, 2022, 29 days after receiving the submission on February 22, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K220492 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2022
Decision Date	March 23, 2022
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390