Cleared Traditional

SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

K111540 · Synthes (Usa) · Orthopedic
Aug 2011
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K111540 is an FDA 510(k) clearance for the SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on August 8, 2011, 67 days after receiving the submission on June 2, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K111540 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2011
Decision Date August 08, 2011
Days to Decision 67 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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