Cleared Special

OsteoRemedies Hip Spacer System

K192995 · Osteoremedies, LLC · Orthopedic
Jan 2020
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K192995 is an FDA 510(k) clearance for the OsteoRemedies Hip Spacer System, 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 January 10, 2020, 77 days after receiving the submission on October 25, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K192995 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2019
Decision Date January 10, 2020
Days to Decision 77 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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