Cleared Traditional

SPACER-S TEMPORARY SHOULDER SPACER

K060535 · Tecres S.P.A. · Orthopedic
May 2006
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K060535 is an FDA 510(k) clearance for the SPACER-S TEMPORARY SHOULDER SPACER, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Tecres S.P.A. (Gainesville, US). The FDA issued a Cleared decision on May 24, 2006, 85 days after receiving the submission on February 28, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K060535 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2006
Decision Date May 24, 2006
Days to Decision 85 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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