Cleared Traditional

2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES

K102694 · Synthes (Usa) · Orthopedic
Dec 2010
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K102694 is an FDA 510(k) clearance for the 2.4MM VA-LCP DORSAL DISTAL RADIUS 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 December 9, 2010, 80 days after receiving the submission on September 20, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K102694 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2010
Decision Date December 09, 2010
Days to Decision 80 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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