Cleared Traditional

SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)

K120717 · Synthes (Usa) · Orthopedic
May 2012
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K120717 is an FDA 510(k) clearance for the SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS 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 8, 2012, 61 days after receiving the submission on March 8, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K120717 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2012
Decision Date May 08, 2012
Days to Decision 61 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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