Cleared Traditional

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE

K121601 · Synthes (Usa) · Orthopedic
Jul 2012
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K121601 is an FDA 510(k) clearance for the SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on July 6, 2012, 35 days after receiving the submission on June 1, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K121601 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2012
Decision Date July 06, 2012
Days to Decision 35 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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