FDA Registration
Active
🇺🇸 United States
MD ORTHOPAEDICS
Reg #: 3005663580
·
FEI: 3005663580
·
Expires 2026
Products
9
Proprietary Names
10
Establishment Types
4
Classifications
9
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Registration Details
- Registration Name
- MD ORTHOPAEDICS
- Registration Number
- 3005663580
- FEI Number
- 3005663580
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 604 NORTH PARKWAY ST
- City
- Wayland
- State
- IA
- ZIP
- 52654
- Country
- US
Owner / Operator
- Firm Name
- MD Orthopaedics, Inc.
- Operator Number
- 9083122
- Address
- 604 NORTH PARKWAY ST, --
- City
- Wayland
- State
- IA
- Postal Code
- 52654
- Country
- US
- Correspondent
- Yan Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2023-12-13 |
| Splint, Denis Brown | ITN | Class 1 | Physical Medicine | No | 2006-02-16 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2023-12-13 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2023-12-13 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2019-09-05 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2006-02-16 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2023-12-13 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2023-12-13 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2023-12-13 |
Proprietary Names
Rhino
Ponseti® Plus Abduction Bar
Ponseti® Lite Abduction Bar
Mitchell Ponseti® Move Bar
PONSETI Bar
Unilateral Brace
Shoe Adapter
Ponseti® Ankle Foot Orthosis AFO
Ponseti® Lite Boots
Shoe Accessories
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device