Cleared Traditional

Geminus Volar Distal Radius Plating System

K252949 · Skeletal Dynamics, Inc. · Orthopedic
Nov 2025
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K252949 is an FDA 510(k) clearance for the Geminus Volar Distal Radius 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 November 13, 2025, 58 days after receiving the submission on September 16, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K252949 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2025
Decision Date November 13, 2025
Days to Decision 58 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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