Cleared Traditional

VARIAX ELBOW SYSTEM

K101056 · Howmedica Osteonics Corp. · Orthopedic
May 2010
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K101056 is an FDA 510(k) clearance for the VARIAX ELBOW SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on May 13, 2010, 28 days after receiving the submission on April 15, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K101056 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2010
Decision Date May 13, 2010
Days to Decision 28 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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