Data / Medical devices / United States / Simpex Medical, Inc.
Simpex Medical, Inc.: FDA-registered device maker in Fort Mill, SC, United States, 2 510(k) clearances
Simpex Medical, Inc. is registered with the FDA (registration 3025266) in Fort Mill, SC, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 12, 1991. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025266
- FEI number
- 1000126034
- Address
- 1974 Carolina Place Drive Suite 216-A, Fort Mill, SC, United States, 29708
- Owner or operator
- SIMPEX MEDICAL, INC. (9002476)
- Roles
- Specification developer
- First device listed
- January 3, 2008
- Registered through
- 2026
- Brand names listed
- Drill Bit, Drill Bit Round Shank, K-Wire, Kirschner Wire, Steinmann Pin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 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 |
|---|---|---|---|---|---|---|
| April 12, 1991 | K911505 | FIXATION WIRE | HTY | Substantially Equivalent | Simpex, Inc. | accessdata.fda.gov |
| April 12, 1991 | K911452 | FIXATION PIN | HTY | Substantially Equivalent | Simpex, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 12, 1991. 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.