Cleared Special

REMEDY Acetabular Cup

K191981 · Osteoremedies, LLC · Orthopedic
Aug 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K191981 is an FDA 510(k) clearance for the REMEDY Acetabular Cup, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Osteoremedies, LLC (Germantown, US). The FDA issued a Cleared decision on August 23, 2019, 30 days after receiving the submission on July 24, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K191981 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2019
Decision Date August 23, 2019
Days to Decision 30 days
Submission Type Special
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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