Cleared Traditional

COPAL? exchange G hip spacer; COPAL? G+V

K234028 · Heraeus Medical GmbH · Orthopedic
Feb 2024
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K234028 is an FDA 510(k) clearance for the COPAL? exchange G hip spacer; COPAL? G+V, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on February 15, 2024, 57 days after receiving the submission on December 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K234028 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2023
Decision Date February 15, 2024
Days to Decision 57 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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