Cleared Traditional

Skeletal Dynamics Ulnar Shortening Plating System

K201962 · Skeletal Dynamics, Inc. · Orthopedic
Oct 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K201962 is an FDA 510(k) clearance for the Skeletal Dynamics Ulnar Shortening Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on October 13, 2020, 90 days after receiving the submission on July 15, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K201962 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2020
Decision Date October 13, 2020
Days to Decision 90 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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