FDA Registration
Active
🇺🇸 United States
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Proximal Reamer 6MM
Reg #: 1645151
·
FEI: 1000118610
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CENTEX MACHINING, INC.
- Registration Number
- 1645151
- FEI Number
- 1000118610
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1513 SAM BASS ROAD
- City
- Round Rock
- State
- TX
- ZIP
- 78681
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122692
Owner / Operator
- Firm Name
- Centex Machining by Fathom
- Operator Number
- 10061953
- Address
- 1513 Sam Bass Rd.
- City
- Round Rock
- State
- TX
- Postal Code
- 78681
- Country
- US
- Correspondent
- Donald O Atkins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-03-04 |
Proprietary Names
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Proximal Reamer 6MM
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Reamer Body 8MM
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Reamer Body 6MM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)