Data / Medical devices / Costa Rica / Microport Orthopedics, S.A.
Microport Orthopedics, S.A.: FDA-registered device maker in Sabana Norte San Jose, Costa Rica, 2 510(k) clearances
Microport Orthopedics, S.A. is registered with the FDA (registration 3010856250) in Sabana Norte San Jose, Costa Rica. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 5, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010856250
- Address
- Edificio Torre La Sabana, Piso 9 Avenida de las Americas y Calle 60, Sabana Norte San Jose, Costa Rica, 10108
- Owner or operator
- MicroPort Orthopedics Inc. (10045253)
- Roles
- Specification developer
- First device listed
- February 1, 2014
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Knee Arthroplasty Implantation System | OOG | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 5, 2022 | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | MBH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| October 17, 2011 | K103598 | PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | MBH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Knee Arthroplasty Implantation System
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated January 5, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.