FDA Registration
Active
🇺🇸 United States
SKELETAL DYNAMICS, INC
Reg #: 3006742481
·
FEI: 3006742481
·
Expires 2026
Products
17
Proprietary Names
26
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- SKELETAL DYNAMICS, INC
- Registration Number
- 3006742481
- FEI Number
- 3006742481
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7300 N Kendall Drive, Suite 800
- City
- Miami
- State
- FL
- ZIP
- 33156
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111620
Owner / Operator
- Firm Name
- Skeletal Dynamics, Inc
- Operator Number
- 10034431
- Address
- 7300 N Kendall Drive, Suite 800
- City
- Miami
- State
- FL
- Postal Code
- 33156
- Country
- US
- Correspondent
- Mario A Arbesu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2011-12-06 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2011-12-06 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2024-09-05 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2023-05-19 |
| Internal Hinged Elbow Fixator | OZI | Class 2 | Orthopedic | No | 2023-05-19 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2021-10-06 |
| Prosthesis, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2013-12-20 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2011-06-07 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2010-12-01 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2024-09-05 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-09-05 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-02-14 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2021-10-05 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-10-06 |
| Instruments Designed For Press-Fit Osteochondral Implants | QBO | Class 2 | Orthopedic | No | 2021-10-06 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2021-10-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-10-06 |
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
Small Bone Fixation System
Stablyx
FreeFix Foream Plating System
Skeletal Dynamics Midshaft Humerus Plating System
IJS-Elbow
Distal Humerus Plating System
Proximal Humerus Fixation System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device