FDA Registration
Active
🇸🇲 San Marino
PRIMA Humeral System and SMR Glenosphere diam. 42
Reg #: 3009475821
·
FEI: 3009475821
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- LSM-MED S.r.l.
- Registration Number
- 3009475821
- FEI Number
- 3009475821
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Strada Borrana 38
- City
- Serravalle San Marino Citta
- Country
- SM
Regulatory Submissions
- 510(k) Number
- K212800
Owner / Operator
- Firm Name
- LSM-MED S.r.l.
- Operator Number
- 10038496
- Address
- Strada Borrana 38
- City
- Serravalle
- State
- SM-09
- Postal Code
- 47899
- Country
- SM
- Correspondent
- Riccardo Rossi
US Agent
- Business Name
- Peoples & Associates Consulting LLC
- Contact Name
- Stephen Peoples
- Address
- 329 Peninsula Drive
- City
- Fort Wayne
- State
- IN
- ZIP
- 46814
- Country
- US
- [email protected]
- Phone
- 260 6450327
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2023-12-07 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2023-12-07 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2023-12-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2023-12-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2023-12-07 |
Proprietary Names
PRIMA Humeral System and SMR Glenosphere diam. 42
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)