Cleared Traditional

Remedy Acetabular Cup

K173967 · Osteoremedies, LLC · Orthopedic
Feb 2018
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K173967 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 (Memphis, US). The FDA issued a Cleared decision on February 22, 2018, 55 days after receiving the submission on December 29, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K173967 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2017
Decision Date February 22, 2018
Days to Decision 55 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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