FDA Registration
Active
🇺🇸 United States
SAHTNEM6 HUMERAL TRAY NEUTRAL -6MM EXT
Reg #: 1834379
·
FEI: 1000306303
·
Expires 2025
Products
5
Proprietary Names
11
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- MICROPULSE INC
- Registration Number
- 1834379
- FEI Number
- 1000306303
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5865 E State Road 14
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213856
Owner / Operator
- Firm Name
- Micropulse
- Operator Number
- 10042100
- Address
- 5865 E State Road 14
- City
- Columbia City
- State
- IN
- Postal Code
- 46725
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2023-04-17 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2023-04-17 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2023-04-17 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2023-04-17 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2023-04-17 |
Proprietary Names
SAHTNEM6 HUMERAL TRAY NEUTRAL -6MM EXT
SAHTNE06 HUMERAL TRAY NEUTRAL 6MM
SAHTST12 HUM TRAY NEUTRAL +12MM STD
SAHTRT00 HUMERAL TRAY RIGHT 0MM
SAHTNE12 HUMERAL TRAY NEUTRAL 12MM
SAHTLT00 HUMERAL TRAY LEFT 0MM
SAHTNE00 HUMERAL TRAY NEUTRAL 0MM
SAHTRTM6 HUMERAL TRAY RIGHT -6MM EXT
SAHTST00 HUM TRAY NEUTRAL +0MM STD
SAHTST06 HUM TRAY NEUTRAL +6MM STD
SAHTLTM6 HUMERAL TRAY LEFT -6MM EXT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)