FDA Registration
Active
🇨🇦 Canada
Mesh, surgical
Reg #: 3010400367
·
FEI: 3010400367
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- TRIBE MEDICAL GROUP
- Registration Number
- 3010400367
- FEI Number
- 3010400367
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 595 Industrial Road
- City
- London Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K103787
Owner / Operator
- Firm Name
- Tribe Medical Group
- Operator Number
- 10082587
- Address
- 595 Industrial Road
- City
- London
- State
- Ontario
- Postal Code
- N5V 1V2
- Country
- CA
US Agent
- Business Name
- Arthrex Inc
- Contact Name
- Barry Dietz
- Address
- 1370 Creekside Blvd
- City
- Naples
- State
- FL
- ZIP
- 34108
- Country
- US
- [email protected]
- Phone
- 800 9337001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | OXB | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
Proprietary Names
Mesh, surgical
Establishment Types
Export Device to the United States But Perform No Other Operation on Device