FDA Registration
Active
🇮🇹 Italy
STI LUALDI S.R.L.
Reg #: 3026771806
·
FEI: 3026771806
·
Expires 2026
Products
26
Proprietary Names
36
Establishment Types
1
Classifications
26
Registration Details
- Registration Name
- STI LUALDI S.R.L.
- Registration Number
- 3026771806
- FEI Number
- 3026771806
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via del Molino 36
- City
- Casiacco Pordenone
- Country
- IT
Owner / Operator
- Firm Name
- STI Lualdi S.r.l.
- Operator Number
- 10092679
- Address
- Via del Molino 36
- City
- Casiacco
- State
- Pordenone
- Postal Code
- 33090
- Country
- IT
- Correspondent
- Anna Gerometta
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stepan Toupin
- Address
- 7320 Nw 12th St
- City
- Doral
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2025-02-10 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-02-10 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2025-02-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-02-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2025-02-08 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2025-12-22 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2025-12-22 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-02-08 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-02-08 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-02-08 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-02-08 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-02-10 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2025-02-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-02-08 |
| Template | HWT | Class 1 | Orthopedic | No | 2025-12-22 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2025-02-10 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-02-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-02-08 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2025-02-08 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2025-02-10 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2025-02-10 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-02-10 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2025-02-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2025-02-07 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2025-02-07 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2025-02-07 |
Proprietary Names
Physica CR Knee System
C2 femoral stem
TEMA Elbow System
SMR TT Augmented Glenoid System
BIT, DRILL
Delta Dual Mobility System
Template
Bone Screws 6.5 mm
PRIMA Humeral System
SMR Glenosphere Dia. 42
PRIMA Humeral System; PRIMA TT Glenoid
SMR Shoulder System
SMR 40mm Glenosphere
Physica PS Knee System
SMR TT Metal Back Glenoid Bone Graft instruments
Orthopedic manual surgical instrument
SMR Stemless Anatomic
AWL
CMD 24-1278 ProMade Hip
CMD 24-1137 ProMade Hip
CMD 24-1336 ProMade Hip
CMD 24-1298 ProMade Hip
Bone Screws dia. 5 mm
SCREWDRIVER
AMF Revision TT Cones
MASTER SL FEMORAL STEM
H-Max S femoral stems
SMR 3-PEGS GLENOIDS
SMR Resurfacing
PRIMA TT Glenoid
PHYSICA KR KNEE SYSTEM
Modulus femoral stems; Modular heads; Lock Bipolar heads; Cemented cups
SMR Hybrid Glenoid System
SMR Modular Glenoid
SMR 3-Pegs Glenoids
Delta TT Cups; Delta Liners
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)