Data / Medical devices / United States / Amplio Spine
Amplio Spine: FDA-registered device maker in Boca Raton, FL, United States, 1 510(k) clearance
Amplio Spine is registered with the FDA (registration 3047379549) in Boca Raton, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 19, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3047379549
- Address
- 1060 Holland Drive, Suite G, Boca Raton, FL, United States, 33487
- Owner or operator
- Amplio Spine (10096118)
- Roles
- Specification developer
- First device listed
- June 29, 2026
- Registered through
- 2026
- Brand names listed
- KeyLift Expandable Interlaminar Stabilization System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Spinous Process Plate | PEK | 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 |
|---|---|---|---|---|---|---|
| October 19, 2023 | K232484 | KeyLift Expandable Interlaminar Stabilization System | PEK | Substantially Equivalent | Amplio Spine, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 19, 2023. 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.