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

FDA 510(k) cleared devices by Skeletal Dynamics, Inc. Orthopedic

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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