FDA Registration
Active
🇺🇸 United States
Arthrex Pec Repair Button, Large Pec Button, Biceps Button and Proximal Biceps Button
Reg #: 3010331645
·
FEI: 3010331645
·
Expires 2025
Products
1
Proprietary Names
1
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
- K123341
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 |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2013-03-08 |
Proprietary Names
Arthrex Pec Repair Button, Large Pec Button, Biceps Button and Proximal Biceps Button
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)