Medical Device Manufacturer · US , Miami , FL

Skeletal Dynamics, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2020

Recent clearances: Clavicle Fixation System, Geminus Volar Distal Radius Plating System, Proximal Humerus Fixation System

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Skeletal Dynamics, Inc. Orthopedic ✕

21 devices

1-12 of 21

Cleared Jul 29, 2026

Suture Button Repair System

Orthopedic · 61d

Cleared Mar 23, 2026

Clavicle Fixation System

Orthopedic · 82d

Cleared Nov 13, 2025

Geminus Volar Distal Radius Plating System

Orthopedic · 58d

Cleared Nov 14, 2024

Proximal Humerus Fixation System

Orthopedic · 90d

Cleared Nov 01, 2024

Total Wrist Arthroplasty System (TWA)

Orthopedic · 2d

Cleared Sep 26, 2024

Protean Fragment Plating System

Orthopedic · 94d

Cleared Aug 01, 2024

Freefix Forearm Plating System

Orthopedic · 17d

Cleared Jul 19, 2024

Suture Button Repair System

Orthopedic · 115d

Cleared Dec 15, 2023

Double Internal Joint Stabilizer- Elbow

Orthopedic · 211d

Cleared Sep 28, 2023

ALIGN Radial Head System

Orthopedic · 155d

Cleared Aug 28, 2023

Distal Elbow Plating System

Orthopedic · 87d

Cleared May 10, 2023

Internal Joint Stabilizer - Elbow

Orthopedic · 194d