FDA Registration
Active
🇺🇸 United States
Buechel-Pappas Humeral Stem Component
Reg #: 3006085220
·
FEI: 3006085220
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- E. BAC SI IMPORTS LLC
- Registration Number
- 3006085220
- FEI Number
- 3006085220
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 631 Canyon Rivers Edge Road
- City
- Ellensburg
- State
- WA
- ZIP
- 98926
- Country
- US
Regulatory Submissions
- 510(k) Number
- K904880
Owner / Operator
- Firm Name
- E. BAC SI IMPORTS LLC
- Operator Number
- 9089402
- Address
- 110 W. 6th Ave, Suite 342
- City
- Ellensburg
- State
- WA
- Postal Code
- 98926
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-05-08 |
Proprietary Names
Buechel-Pappas Humeral Stem Component
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility