Cleared Traditional

Spacer-G and Spacer-K

K101356 · Tecres S.P.A. · Orthopedic
Sep 2011
Decision
494d
Days
Class 2
Risk

About This 510(k) Submission

K101356 is an FDA 510(k) clearance for the Spacer-G and Spacer-K, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on September 20, 2011, 494 days after receiving the submission on May 14, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K101356 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2010
Decision Date September 20, 2011
Days to Decision 494 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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