Data / Medical devices / United Kingdom / MatOrtho Limited
MatOrtho Limited: FDA-registered device maker in Plymouth Devon, United Kingdom, 1 510(k) clearance
MatOrtho Limited is registered with the FDA (registration 3016096064) in Plymouth Devon, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 17, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016096064
- Address
- 9a Kay Close Plymton, Plymouth Devon, United Kingdom, PL7 4LU
- Owner or operator
- MatOrtho Limited (10036804)
- Roles
- Manufacturer
- First device listed
- November 21, 2014
- Registered through
- 2026
- Brand names listed
- SAIPH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 17, 2014 | K140222 | SAIPH KNEE SYSTEM | JWH | Substantially Equivalent | Matortho | accessdata.fda.gov |
Compare with other makers
Updated November 17, 2014. 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.