Cleared Traditional

SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM

K120070 · Synthes (Usa) · Orthopedic
Mar 2012
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K120070 is an FDA 510(k) clearance for the SYNTHES VARIABLE ANGLE LCP ELBOW 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 March 21, 2012, 72 days after receiving the submission on January 9, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K120070 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2012
Decision Date March 21, 2012
Days to Decision 72 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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