Cleared Traditional

SPACER-S

K112983 · Tecres S.P.A. · Orthopedic
Dec 2011
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K112983 is an FDA 510(k) clearance for the SPACER-S, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on December 12, 2011, 67 days after receiving the submission on October 6, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K112983 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2011
Decision Date December 12, 2011
Days to Decision 67 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

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