Data / Medical devices / United States / Response Ortho Solutions LLC
Response Ortho Solutions LLC: FDA-registered device maker in Boynton Beach, FL, United States, 2 510(k) clearances
Response Ortho Solutions LLC is registered with the FDA (registration 3045159437) in Boynton Beach, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045159437
- Address
- 1875 W Woolbright Rd, Boynton Beach, FL, United States, 33426
- Owner or operator
- Response Ortho Solutions LLC (10095923)
- Roles
- Manufacturer
- First device listed
- May 22, 2026
- Registered through
- 2026
- Brand names listed
- Response Ortho Metaphyseal Hinge Fixator System, Response Ortho Smart Fixator - Hexapod System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 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 20, 2025 | K252625 | The Response Ortho Smart Fixator - Hexapod System | KTT | Substantially Equivalent | Response Ortho Solutions, LLC | accessdata.fda.gov |
| September 18, 2024 | K241769 | Response Ortho Metaphyseal Hinge Fixator System | KTT | Substantially Equivalent | Response Ortho Solutions, LLC | accessdata.fda.gov |
Compare with other makers
Updated November 20, 2025. 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.