Cleared Traditional

MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM

K053624 · Medicon EG · Orthopedic
Jul 2006
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K053624 is an FDA 510(k) clearance for the MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Medicon EG (Amsterdam, Nh, NL). The FDA issued a Cleared decision on July 17, 2006, 201 days after receiving the submission on December 28, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K053624 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2005
Decision Date July 17, 2006
Days to Decision 201 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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