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Skeletal Dynamics, Inc.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories7
Latest FDA decision2026-07-29
TypeNumberDevice NameCodeDateActions
510(k) K261770 Suture Button Repair SystemMBI2026-07-29 View
510(k) K254288 Clavicle Fixation SystemHRS2026-03-23 View
510(k) K252949 Geminus Volar Distal Radius Plating SystemHRS2025-11-13 View
510(k) K242436 Proximal Humerus Fixation SystemHRS2024-11-14 View
510(k) K243381 Total Wrist Arthroplasty System (TWA)JWJ2024-11-01 View
510(k) K241815 Protean Fragment Plating SystemHRS2024-09-26 View
510(k) K242055 Freefix Forearm Plating SystemHRS2024-08-01 View
510(k) K240835 Suture Button Repair SystemMBI2024-07-19 View
510(k) K231447 Double Internal Joint Stabilizer- ElbowOZI2023-12-15 View
510(k) K231188 ALIGN Radial Head SystemKWI2023-09-28 View
510(k) K231623 Distal Elbow Plating SystemHRS2023-08-28 View
510(k) K223318 Internal Joint Stabilizer - ElbowOZI2023-05-10 View
510(k) K230908 Hand Trauma Threaded Nail SystemHWC2023-04-28 View
510(k) K220723 Hand Trauma Screw SystemHWC2022-05-12 View
510(k) K213895 Distal Humerus Plating SystemHRS2022-01-13 View
510(k) K211439 Small Bone Nailing SystemHTY2021-09-30 View
510(k) K201962 Skeletal Dynamics Ulnar Shortening Plating SystemHRS2020-10-13 View
510(k) K201662 REDUCT® Headless Compression Screw SystemHWC2020-07-16 View
510(k) K200538 Skeletal Dynamics Forearm Plating SystemHRS2020-06-01 View
510(k) K200701 Skeletal Dynamics Midshaft Humerus Plating SystemHRS2020-05-14 View

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