Cleared Special

SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT

K103104 · Howmedica Osteonics Corp. · Orthopedic
Nov 2010
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K103104 is an FDA 510(k) clearance for the SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on November 22, 2010, 33 days after receiving the submission on October 20, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number K103104 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2010
Decision Date November 22, 2010
Days to Decision 33 days
Submission Type Special
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

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