FDA Registration
Active
🇨🇳 China
ANKLE HINDFOOT NAILING SYSTEM - INSERTION INSTRUMENTS CASE EMPTY
Reg #: 3007539489
·
FEI: 3007539489
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Paragon Medical Device (Changzhou) Co., Ltd.
- Registration Number
- 3007539489
- FEI Number
- 3007539489
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3A GDH Industrial Park, No. 16 Chuangye Road
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K141571
Owner / Operator
- Firm Name
- Paragon Medical
- Operator Number
- 9011072
- Address
- 8 Matchett Dr., --
- City
- Pierceton
- State
- IN
- Postal Code
- 46562
- Country
- US
- Correspondent
- Stephane Langlois
US Agent
- Business Name
- Paragon Medical
- Contact Name
- Stephane Langlois
- Address
- 8 Matchett Dr
- City
- Pierceton
- State
- IN
- ZIP
- 46562
- Country
- US
- [email protected]
- Phone
- 435 5355456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2015-12-14 |
Proprietary Names
ANKLE HINDFOOT NAILING SYSTEM - INSERTION INSTRUMENTS CASE EMPTY
ANKLE HINDFOOT NAILING SYSTEM - DRILLS AND REAMERS CASE EMPTY
ANKLE HINDFOOT NAILING SYSTEM - EXTRACTION INSTRUMENTS CASE EMPTY
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)