FDA Registration
Active
🇺🇸 United States
Arthrex, Inc.
Reg #: 3010331645
·
FEI: 3010331645
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
2
Classifications
1
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
- K183628
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-03-29 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)