FDA Registration
Active
🇺🇸 United States
SEVIIN Reverse Shoulder
Reg #: 3005130928
·
FEI: 3005130928
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INGEN ORTHOPEDICS LLC
- Registration Number
- 3005130928
- FEI Number
- 3005130928
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 68 Mussey Road
- City
- Scarborough
- State
- ME
- ZIP
- 04074
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120374
Owner / Operator
- Firm Name
- Ingen Orthopedics LLC
- Operator Number
- 9072056
- Address
- 68 Mussey Road
- City
- Scarborough
- State
- ME
- Postal Code
- 04074
- Country
- US
- Correspondent
- JOSEPH - AZARY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2018-12-28 |
Proprietary Names
SEVIIN Reverse Shoulder
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility