Data / Medical devices / Prosthesis, Toe, Constrained, Polymer / United States
FDA-registered makers of Prosthesis, Toe, Constrained, Polymer in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Prosthesis, Toe, Constrained, Polymer (product code KWH). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Prosthesis, Toe, Constrained, Polymer
- Product code
- KWH
- Country
- United States
Makers of Prosthesis, Toe, Constrained, Polymer in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 4 | January 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Fusion Orthopedics Usa, LLC | Mesa, AZ, United States | Complaint file establishment, Specification developer | 3 | October 21, 2019 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 3 | January 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 3 | January 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| In2bones Usa, LLC | Cordova, TN, United States | Manufacturer | 2 | February 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Manufacturer | 2 | November 26, 2002 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 1 | January 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Medical Device And Implants LLC | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.