FDA Registration
Active
🇺🇸 United States
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
Reg #: 3004464325
·
FEI: 3004464325
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- DEPUY ORTHOPAEDICS
- Registration Number
- 3004464325
- FEI Number
- 3004464325
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 50 SCOTLAND BLVD.
- City
- BRIDGEWATER
- State
- MA
- ZIP
- 02324
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091499
Owner / Operator
- Firm Name
- DePuy Synthes, Inc.
- Operator Number
- 1818910
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2023-08-17 |
| Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | OXB | Class 2 | General, Plastic Surgery | No | 2023-08-17 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2023-08-17 |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | Class 2 | General, Plastic Surgery | No | 2023-08-17 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2023-08-17 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2023-08-17 |
Proprietary Names
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
Establishment Types
Repack or Relabel Medical Device