FDA Registration
Active
🇺🇸 United States
BLUEPRINT PATIENT SPECIFIC INSTRUMENTATION
Reg #: 3014252644
·
FEI: 3014252644
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- C&A Tool Engineering, Inc. Auburn Plant
- Registration Number
- 3014252644
- FEI Number
- 3014252644
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1015 W 15th St
- City
- Auburn
- State
- IN
- ZIP
- 46706
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160555
Owner / Operator
- Firm Name
- MinebeaMitsumi Inc.
- Operator Number
- 10055758
- Address
- 3-9-6 Mita
- City
- Minato-ku
- State
- Tokyo
- Postal Code
- 108-8330
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-05-14 |
Proprietary Names
BLUEPRINT PATIENT SPECIFIC INSTRUMENTATION
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)