Cleared Traditional

2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

K110125 · Synthes (Usa) · Orthopedic
Apr 2011
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K110125 is an FDA 510(k) clearance for the 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS 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 April 21, 2011, 93 days after receiving the submission on January 18, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K110125 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2011
Decision Date April 21, 2011
Days to Decision 93 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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