FDA Registration
Active
🇺🇸 United States
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi
Reg #: 3010331645
·
FEI: 3010331645
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Arthrex, Inc.
- Registration Number
- 3010331645
- FEI Number
- 3010331645
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6875 Arthrex Commerce Drive
- City
- Ave Maria
- State
- FL
- ZIP
- 34142
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162697
Owner / Operator
- Firm Name
- ARTHREX, INC.
- Operator Number
- 1220287
- Address
- 1370 CREEKSIDE BLVD., --
- City
- Naples
- State
- FL
- Postal Code
- 34108
- Country
- US
- Correspondent
- Barry Dietz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2018-05-18 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-05-18 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2018-05-18 |
Proprietary Names
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)