Data / Medical devices / United Kingdom / Matortho Limited
Matortho Limited: FDA-registered device maker in Leatherhead Surrey, United Kingdom, 1 510(k) clearance
Matortho Limited is registered with the FDA (registration 3008985661) in Leatherhead Surrey, United Kingdom. It lists 2 device types. 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
- 3008985661
- Address
- 19/20 Mole Business Park Randalls Road, Leatherhead Surrey, United Kingdom, KT22 7BA
- Owner or operator
- MatOrtho Limited (10036804)
- Roles
- Manufacturer
- First device listed
- May 27, 2011
- Registered through
- 2026
- Brand names listed
- SAIPH, Tuke Saw Blade
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Manufacturer | accessdata.fda.gov |
| 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
- All makers of Blade, Saw, General & Plastic Surgery, Surgical
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.