Cleared Special

Distal Humerus Plating System

K213895 · Skeletal Dynamics, Inc. · Orthopedic
Jan 2022
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K213895 is an FDA 510(k) clearance for the Distal Humerus 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 January 13, 2022, 30 days after receiving the submission on December 14, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K213895 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2021
Decision Date January 13, 2022
Days to Decision 30 days
Submission Type Special
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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