FDA Registration
Active
🇺🇸 United States
Hemiphalangeal Implant System
Reg #: 3010531069
·
FEI: 3010531069
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PRO-TECH Design & Mfg, Inc.
- Registration Number
- 3010531069
- FEI Number
- 3010531069
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4041 Express Street
- City
- Arlington
- State
- TX
- ZIP
- 76001
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120029
Owner / Operator
- Firm Name
- PRO-TECH Design & Mfg, Inc.
- Operator Number
- 9048910
- Address
- 14561 MARQUARDT AVE., --
- City
- Santa Fe Springs
- State
- CA
- Postal Code
- 90670
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2012-10-15 |
Proprietary Names
Hemiphalangeal Implant System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device