Data / Medical devices / United States / Retrofix Screws, LLC
Retrofix Screws, LLC: FDA-registered device maker in Salisbury, NC, United States, 1 510(k) clearance
Retrofix Screws, LLC is registered with the FDA (registration 3017075357) in Salisbury, NC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017075357
- Address
- 710 Mitchell Ave, Salisbury, NC, United States, 28144
- Owner or operator
- Retrofix Screws, LLC (10075980)
- Roles
- Specification developer
- First device listed
- July 2, 2020
- Registered through
- 2026
- Brand names listed
- 4 mm Drill Bit Part No. CTM000884, 4.7 mm Drill Bit Part No. CTM000936, Caddie (Tray) Assembly Part No. AFNM000369, Caddie (Tray) Lid Part No. CTM001163, Cannulated Screwdriver Part No. CTM000893, Depth Gauge Part No. CTM000887, Drill guide -Tissue Protector Part No. CTM000886, K-wire 1.3 x 225 mm Part No. CTM000882 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | 2 | Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | 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 |
|---|---|---|---|---|---|---|
| June 26, 2020 | K200226 | RetroFix | HWC | Substantially Equivalent | Retrofix Screws, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 26, 2020. 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.