FDA Registration
Active
🇺🇸 United States
SLIDE HAMMER ZIMMER NEXEL TOTAL ELBOW
Reg #: 3009887475
·
FEI: 3009887475
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Complexus Medical
- Registration Number
- 3009887475
- FEI Number
- 3009887475
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 55980 Russell Industrial Pkwy
- City
- Mishawaka
- State
- IN
- ZIP
- 46545
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123862
Owner / Operator
- Firm Name
- Complexus Medical
- Operator Number
- 10042212
- Address
- 55980 Russell Industrial Parkway
- City
- Mishawaka
- State
- IN
- Postal Code
- 46545
- Country
- US
- Correspondent
- Michael Behrens
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2018-06-22 |
Proprietary Names
SLIDE HAMMER ZIMMER NEXEL TOTAL ELBOW
ARTICULATION INSERTER ZIMMER NEXEL TOTAL ELBOW
ULNAR CLEARANCE TEMPLATE ZIMMER NEXEL TOTAL ELBOW
ULNAR BEARING ASSY TOOL ZIMMER NEXEL TOTAL ELBOW
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)