FDA Registration
Active
🇺🇸 United States
EVOLUTION® TIBIAL CONES (ETKNCN01-06)
Reg #: 3010536692
·
FEI: 3010536692
·
Expires 2025
Products
3
Proprietary Names
10
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MICROPORT ORTHOPEDICS INC.
- Registration Number
- 3010536692
- FEI Number
- 3010536692
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5677 AIRLINE RD
- City
- Arlington
- State
- TN
- ZIP
- 38002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233507
Owner / Operator
- Firm Name
- MicroPort Orthopedics Inc.
- Operator Number
- 10045253
- Address
- 5677 Airline Road
- City
- Arlington
- State
- TN
- Postal Code
- 38002
- Country
- US
- Correspondent
- Ryan Ross
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2024-08-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-08-15 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-08-15 |
Proprietary Names
EVOLUTION® TIBIAL CONES (ETKNCN01-06)
EVOLUTION® REV CONICAL REAMERS (E2432CN01-06)
EVOLUTION® REV REAMER PILOT (E2432CN11-13)
EVOLUTION® REV CONE EXTRACTOR (E233CN11)
EVOLUTION® REV CONE TRIALS (E3500CN1-6)
EVOLUTION® REV CEMENT KEEL TRIAL (E3500CK1)
EVOLUTION® REV CONICAL BROACHES (E223CN01-06)
EVOLUTION® REV BROACH ADAPTERS (E203CN01-03)
EVOLUTION® REV SPACERS (E5101CN1-4)
EVOLUTION® REV CONE INSERTER (E233CN01-06)
Establishment Types
Manufacture Medical Device