FDA Registration
Active
🇸🇬 Singapore
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi
Reg #: 3014004349
·
FEI: 3014004349
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Arthrex Singapore Pte Ltd.
- Registration Number
- 3014004349
- FEI Number
- 3014004349
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 21 Biopolis Road, Nucleos North Tower Unit 03-08
- City
- Singapore Central Singapore
- Country
- SG
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
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 |
|---|---|---|---|---|---|
| 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
Export Device to the United States But Perform No Other Operation on Device