Cleared Traditional

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement

K172906 · Osteoremedies, LLC · Orthopedic
Aug 2018
Decision
341d
Days
Class 2
Risk

About This 510(k) Submission

K172906 is an FDA 510(k) clearance for the REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement, 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 29, 2018, 341 days after receiving the submission on September 22, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K172906 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2017
Decision Date August 29, 2018
Days to Decision 341 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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