Cleared Traditional

SPACER-G TEMPORARY HIP PROSTHESIS

K062273 · Tecres S.P.A. · Orthopedic
May 2008
Decision
654d
Days
Class 2
Risk

About This 510(k) Submission

K062273 is an FDA 510(k) clearance for the SPACER-G TEMPORARY HIP PROSTHESIS, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Tecres S.P.A. (Gainesville, US). The FDA issued a Cleared decision on May 22, 2008, 654 days after receiving the submission on August 7, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K062273 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2006
Decision Date May 22, 2008
Days to Decision 654 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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