SKELETAL DYNAMICS, INC

FDA Device Registration & Listing · Miami, FL, US · Registration 3006742481

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006742481
FEI Number
3006742481
Entity Name
SKELETAL DYNAMICS, INC
City/State/Country
Miami, FL, US
Establishment Address
7300 N Kendall Drive, Suite 800, Miami, FL 33156, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Skeletal Dynamics, Inc (Owner Number: 10034431)
Owner / Operator Contact Address
7300 N Kendall Drive, Suite 800, Miami, FL 33156, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252949
PMA Number
N/A

All Registered Proprietary Names

Geminus Volar Plating System Hand Trauma Threaded Nail Distal Elbow Plating System Align Radial Head FREEFIX Ulnar Shortening System Ulnar Shortening Plating System Distal Humerus Plating system Protean Fragment Plating System PUP- Internal Joint Stabilizer- Elbow Skeletal Dynamics Forearm Plating System Clavicle Fixation System Skeletal Dynamics Sterilization Trays Wrist Arthrodesis Nail System Geminus XL Total Wrist Arthroplasty ALIGN Radial Head System REDUCT® Headless Compression Screw System Suture-Button Repair System GEMINUS Marginal Fragment Plating System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-12-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-12-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-07
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2024-09-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-11-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-02-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-05-19
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2023-05-19
OZI Internal Hinged Elbow Fixator Orthopedic Class 2 888.3030 2023-05-19
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2024-04-01
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2021-10-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-06-25
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2013-12-20
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2024-04-01
OZI Internal Hinged Elbow Fixator Orthopedic Class 2 888.3030 2024-04-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-04
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2011-06-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-22
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2010-12-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-03-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-22
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic Class 2 888.3800 2024-09-05
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2011-01-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-09-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-01-14

Official Correspondent

Mario Arbesu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Skeletal Dynamics, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3017609305 PRIMEMED INC. Sungnam-city Gyeonggi, KR
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006742481. Last updated year: 2026. Please use registration number 3006742481 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.