Cleared Traditional

SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES

K092812 · Synthes (Usa) · Orthopedic
May 2010
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K092812 is an FDA 510(k) clearance for the SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on May 11, 2010, 239 days after receiving the submission on September 14, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K092812 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2009
Decision Date May 11, 2010
Days to Decision 239 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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