Data / Medical devices / United States / S2ortho, LLC
S2ortho, LLC: FDA-registered device maker in Yardley, PA, United States, 8 510(k) clearances
S2ortho, LLC is registered with the FDA (registration 3043026734) in Yardley, PA, United States. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043026734
- Address
- 1589 Big Oak Rd, Yardley, PA, United States, 19067
- Owner or operator
- S2ORTHO, LLC (10094785)
- Roles
- Specification developer
- First device listed
- December 23, 2025
- Registered through
- 2026
- Brand names listed
- Cannulated Screw, Distal Radius Plating System, Injection Screw, MDS Plating System, Olecranon Plating System, Proximal Humerus Plating System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 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 |
|---|---|---|---|---|---|---|
| December 10, 2018 | K182810 | Distal Radius Plating System | HRS | Substantially Equivalent | Miami Device Solutions, LLC | accessdata.fda.gov |
| July 13, 2018 | K173556 | Injection Screw | HWC | Substantially Equivalent | Biedermann Medtech, Inc. | accessdata.fda.gov |
| December 8, 2017 | K172786 | MDS Plating System | HRS | Substantially Equivalent | Miami Device Solutions, LLC | accessdata.fda.gov |
| March 17, 2017 | K162898 | Olecranon Plating System | HRS | Substantially Equivalent | Miami Device Solutions, LLC | accessdata.fda.gov |
| October 21, 2016 | K162635 | Distal Radius Plating System | HRS | Substantially Equivalent | Miami Device Solutions, LLC | accessdata.fda.gov |
| August 15, 2016 | K161292 | Distal Radius Plating System | HRS | Substantially Equivalent | Miami Device Solutions, LLC | accessdata.fda.gov |
| July 29, 2016 | K161058 | Cannulated Screw | HWC | Substantially Equivalent | Miami Device Solutions, LLC | accessdata.fda.gov |
| March 20, 2015 | K141493 | PROXIMAL HUMERUS PLATING SYSTEM | HRS | Substantially Equivalent | Miami Device Solutions | accessdata.fda.gov |
Compare with other makers
Updated December 10, 2018. 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.