FDA Registration
Active
🇮🇹 Italy
STERIS SPA
Reg #: 3002806470
·
FEI: 3002806470
·
Expires 2026
Products
26
Proprietary Names
46
Establishment Types
1
Classifications
26
Registration Details
- Registration Name
- STERIS SPA
- Registration Number
- 3002806470
- FEI Number
- 3002806470
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 29, VIA CA BERTONCINA
- City
- SERIATE Bergamo
- Country
- IT
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2022-12-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2022-12-14 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2022-12-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2022-12-14 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-11-24 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2020-01-17 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2020-01-17 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-02-01 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2017-02-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2020-01-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2020-01-17 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2020-01-17 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-12-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-01-17 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2020-01-17 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2024-01-08 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2017-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-01-31 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2017-02-01 |
| System, Transport, Aerobic | JTW | Class 1 | Microbiology | No | 2024-07-29 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2025-11-24 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2025-02-21 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-01-19 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2025-11-20 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2024-04-30 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2017-02-01 |
Proprietary Names
LimaCorpSPA9283 (CC,SR) - Bone screws 5mm
BRM9259 (SR) - BRM Tool Pro 5.6 Screws
LimaCorpSPA9283 (CC,SR) - TEMA Elbow System
LimaCorpSPA9283 (SR) - SMR TT Metal Back Glenoid
LimaCorpSPA9283 (CC,SR) - Physica KR knee system
LimaCorpSPA9283 (SR,CC) - C2 Femoral Stem
LimaCorpSPA9283 (SR) - LimaCorporate Kirschner wire
BRM9259 (SR) - BRM Tool Pro 7 Screws
BRM9259 (SR) - BRM VR Breaking Screws
BRM9259 (SR) - BRM Tool Screws
BRM9259 (SR) - BRM Tool VIP Screws
LimaCorpSPA9283 (SR) - Revision Femoral Stem
LimaCorpSPA9283 (CC,SR) - Delta TT Pro
Lima9283 (CC,SR) - SMR Stemless Anatomic
LimaCorpSPA9283 (CC,SR) - Delta Liners; Delta TT Cups
LimaCorpSPA9283 (CC, SR) - Cemented cups; Lock Bipolar heads; Modular heads; Modulus femoral stems
LimaCorpSPA9283 (CC,SR) - SMR Shoulder System
LimaCorpSPA9283 (CC,SR) - SMR Lateralized connectors with screws
LimaCorpSPA9283 (SR) - SMR Shoulder System
LimaCorpSPA9283 (SR) - Delta TT Jumbo Cups
LimaCorpSPA9283 (CC,SR) - SMR 40mm Glenosphere
LimaCorpSPA9283 (CC,SR) - SMR TT Augmented Glenoid System
LimaCorpSPA9283 (CC,SR) - Physica PS Knee System
BRM9259 (SR) - Percutaneous Burrs
LimaCorpSPA9283 (SR) - SMR Resurfacing
LimaCorpSPA9283 (SR) - Delta Multihole TT Pro Acetabular System
LimaCorpSPA9283 (SR) - CTA heads adaptor for reverse humeral body
LimaCorpSPA9283 (CC,SR) - Revision Femoral Stem
LimaCorpSPA9283 (CC,SR) - SMR Hybrid Glenoid System
LimaCorpSPA9283 (SR) - Master SL Femoral Stem
Lima9283 (CC,SR) - Prima TT Glenoid
LimaCorpSPA9283 (CC) - PRIMA TT Glenoid
LimaCorpSPA9283 (SR) - PRIMA Humeral System; PRIMA TT Glenoid
LimaCorpSPA9283 (CC,SR) - PRIMA Humeral System
LimaCorpSPA9283 (SR,CC) - Bone Screws 6.5mm
LimaCorpSPA9283 (SR,CC) - Delta Dual Mobility System
LimaCorpSPA9283 (CC,SR) - Physica system
LimaCorpSPA9283 (CC,SR) - Revision Bone Screw
LimaCorpSPA9283 (CC,SR) - Bone Screw
LimaCorpSPA9283 (CC,SR) - Locking Bone Screw
Meribel9419 (SR) - Novapak Nasal Sinus Packing and Stent
LimaCorpSPA9283 (SR) - SMR Reverse Shoulder System
LimaCorpSPA9283 (CC,SR) - Minima S System
LimaCorpSPA9283 (SR) - SMR Finned Short Stems
LimaCorpSPA9283 (SR) - H-MAX S stem
LimaCorpSPA9283 (CC,SR) - TEMA Elbow system
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)