FDA Registration
Inactive
🇮🇹 Italy
Trinity EVO Acetabular Shell
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- LINCOTEK BOLOGNA S.R.L.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- via Bruno Buozzi 13 15
- City
- Cadriano di Granarolo, Bologna
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K242744
Owner / Operator
- Firm Name
- Lincotek Bologna s.r.l.
- Operator Number
- 10093624
- Address
- via Bruno Buozzi 13 15
- City
- Cadriano di Granarolo, Bologna
- State
- IT-BO
- Postal Code
- 40057
- Country
- IT
- Correspondent
- Caterina Cazzorla
US Agent
- Business Name
- Surface Dynamics, LLC d/b/a Lincotek Medical
- Contact Name
- Domenico Grieco
- Address
- 3110 Stage Post Dr Ste 117 Bartlett Tn 38133
- City
- Bartlett
- State
- TN
- ZIP
- 38133
- Country
- US
- [email protected]
- Phone
- 901 3053132
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2025-06-25 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-06-25 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-06-25 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2025-06-25 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2025-06-25 |
Proprietary Names
Trinity EVO Acetabular Shell
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)