Cleared Traditional

Remedy? Shoulder Spacer

K152267 · Osteoremedies, LLC · Orthopedic

Dec 2015

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K152267 is an FDA 510(k) clearance for the Remedy? Shoulder Spacer, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Osteoremedies, LLC (Memphis, US). The FDA issued a Cleared decision on December 15, 2015, 126 days after receiving the submission on August 11, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K152267 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2015
Decision Date	December 15, 2015
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660