Medical Device Manufacturer · US , Miami , FL

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

20 submissions · 20 cleared · Since 2020
20
Total
20
Cleared
0
Denied

Skeletal Dynamics, Inc. has 20 FDA 510(k) cleared orthopedic devices. Based in Miami, US.

Latest FDA clearance: Mar 2026. Active since 2020.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Skeletal Dynamics, Inc.
20 devices
1-20 of 20
Cleared Mar 23, 2026
Clavicle Fixation System
K254288 · HRS
Orthopedic · 82d
Cleared Nov 13, 2025
Geminus Volar Distal Radius Plating System
K252949 · HRS
Orthopedic · 58d
Cleared Nov 14, 2024
Proximal Humerus Fixation System
K242436 · HRS
Orthopedic · 90d
Cleared Nov 01, 2024
Total Wrist Arthroplasty System (TWA)
K243381 · JWJ
Orthopedic · 2d
Cleared Sep 26, 2024
Protean Fragment Plating System
K241815 · HRS
Orthopedic · 94d
Cleared Aug 01, 2024
Freefix Forearm Plating System
K242055 · HRS
Orthopedic · 17d
Cleared Jul 19, 2024
Suture Button Repair System
K240835 · MBI
Orthopedic · 115d
Cleared Dec 15, 2023
Double Internal Joint Stabilizer- Elbow
K231447 · OZI
Orthopedic · 211d
Cleared Sep 28, 2023
ALIGN Radial Head System
K231188 · KWI
Orthopedic · 155d
Cleared Aug 28, 2023
Distal Elbow Plating System
K231623 · HRS
Orthopedic · 87d
Cleared May 10, 2023
Internal Joint Stabilizer - Elbow
K223318 · OZI
Orthopedic · 194d
Cleared Apr 28, 2023
Hand Trauma Threaded Nail System
K230908 · HWC
Orthopedic · 28d
Cleared May 12, 2022
Hand Trauma Screw System
K220723 · HWC
Orthopedic · 59d
Cleared Jan 13, 2022
Distal Humerus Plating System
K213895 · HRS
Orthopedic · 30d
Cleared Sep 30, 2021
Small Bone Nailing System
K211439 · HTY
Orthopedic · 143d
Cleared Oct 13, 2020
Skeletal Dynamics Ulnar Shortening Plating System
K201962 · HRS
Orthopedic · 90d
Cleared Jul 16, 2020
REDUCT® Headless Compression Screw System
K201662 · HWC
Orthopedic · 27d
Cleared Jun 01, 2020
Skeletal Dynamics Forearm Plating System
K200538 · HRS
Orthopedic · 90d
Cleared May 14, 2020
Distal Humerus Plating System
K200367 · HRS
Orthopedic · 90d
Cleared May 14, 2020
Skeletal Dynamics Midshaft Humerus Plating System
K200701 · HRS
Orthopedic · 57d
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