Medical Device Manufacturer · US , Miami , FL

Skeletal Dynamics, Inc.

19 submissions · 19 cleared · Since 2020
19
Total
19
Cleared
0
Denied

Skeletal Dynamics, Inc. — FDA 510(k) Submissions

Skeletal Dynamics, Inc. has submitted 19 FDA 510(k) premarket notifications since 2020, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Screw, Fixation, Bone, Internal Hinged Elbow Fixator, Pin, Fixation, Smooth, Prosthesis, Elbow, Hemi-, Radial, Polymer . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
Geminus Volar Distal Radius Plating System
K252949 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2025 58d
Proximal Humerus Fixation System
K242436 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2024 90d
Total Wrist Arthroplasty System (TWA)
K243381 · JWJ Prosthesis, Wrist, 3 Part... · Orthopedic
Nov 2024 2d
Protean Fragment Plating System
K241815 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2024 94d
Freefix Forearm Plating System
K242055 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2024 17d
Suture Button Repair System
K240835 · MBI Fastener, Fixation,... · Orthopedic
Jul 2024 115d
Double Internal Joint Stabilizer- Elbow
K231447 · OZI Internal Hinged Elbow... · Orthopedic
Dec 2023 211d
ALIGN Radial Head System
K231188 · KWI Prosthesis, Elbow, Hemi-,... · Orthopedic
Sep 2023 155d
Distal Elbow Plating System
K231623 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2023 87d
Internal Joint Stabilizer - Elbow
K223318 · OZI Internal Hinged Elbow... · Orthopedic
May 2023 194d
Hand Trauma Threaded Nail System
K230908 · HWC Screw, Fixation, Bone · Orthopedic
Apr 2023 28d
Hand Trauma Screw System
K220723 · HWC Screw, Fixation, Bone · Orthopedic
May 2022 59d
Distal Humerus Plating System
K213895 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2022 30d
Small Bone Nailing System
K211439 · HTY Pin, Fixation, Smooth · Orthopedic
Sep 2021 143d
Skeletal Dynamics Ulnar Shortening Plating System
K201962 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2020 90d
REDUCT? Headless Compression Screw System
K201662 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2020 27d
Skeletal Dynamics Forearm Plating System
K200538 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2020 90d
Distal Humerus Plating System
K200367 · HRS Plate, Fixation, Bone · Orthopedic
May 2020 90d
Skeletal Dynamics Midshaft Humerus Plating System
K200701 · HRS Plate, Fixation, Bone · Orthopedic
May 2020 57d
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