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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

DeviceProduct codeClassRoleSource
Spinous Process PlatePEK2Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 19, 2023K232484KeyLift™ Expandable Interlaminar Stabilization SystemPEKSubstantially EquivalentAmplio Spine, LLCaccessdata.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.