Cleared Traditional

Proximal Humerus Fixation System

K242436 · Skeletal Dynamics, Inc. · Orthopedic
Nov 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K242436 is an FDA 510(k) clearance for the Proximal Humerus Fixation 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 November 14, 2024, 90 days after receiving the submission on August 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242436 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2024
Decision Date November 14, 2024
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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