Cleared Traditional

Distal Elbow Plating System

K231623 · Skeletal Dynamics, Inc. · Orthopedic
Aug 2023
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K231623 is an FDA 510(k) clearance for the Distal Elbow 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 August 28, 2023, 87 days after receiving the submission on June 2, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K231623 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2023
Decision Date August 28, 2023
Days to Decision 87 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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