Cleared Traditional

SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321

K062274 · Tecres S.P.A. · Orthopedic

May 2008

Decision

654d

Days

Class 2

Risk

About This 510(k) Submission

K062274 is an FDA 510(k) clearance for the SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), 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 888.3560.

Submission Details

510(k) Number	K062274 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	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560