FDA Registration
Active
🇺🇸 United States
PSN PS-CPS BOX PROV L SZ 6-7 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
Reg #: 3009887475
·
FEI: 3009887475
·
Expires 2025
Products
3
Proprietary Names
14
Establishment Types
1
Classifications
3
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
- K123459
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, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-08-03 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-08-03 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2018-08-03 |
Proprietary Names
PSN PS-CPS BOX PROV L SZ 6-7 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV R SZ 12 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV L SZ 3 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV R SZ 10-11 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV L SZ 10-11 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS Box Prov Sz 1-R PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV R SZ 3 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV R SZ 6-7 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV L SZ 4-5 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV L SZ 12 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS Box Prov Sz 1-L PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV L SZ 8-9 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV R SZ 4-5 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
PSN PS-CPS BOX PROV R SZ 8-9 PERSONA - CPS ARTICULAR SURFACES AND ASSOCIATED INSTRUMENTS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)