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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record P220031

Device name not on record · Empirical Spine, Inc. · decided 2026-02-12 (APPR)

FDA 510(k) database ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Limiflex Dynamic Sagittal TetherGen 3EMPIRICAL SPINE, INC.SGK00859373004005
Symbol PlateGen 3EMPIRICAL SPINE, INC.LYQ00859373004043
DriverGen 3EMPIRICAL SPINE, INC.LYQ00859373004050
Instrument TrayGen 3EMPIRICAL SPINE, INC.KCT00859373004081
Limiflex Dynamic Sagittal Tether Instrument SetGen 3EMPIRICAL SPINE, INC.KCT00859373004012
HolderGen 3EMPIRICAL SPINE, INC.LYQ00859373004036
TensionerGen 3EMPIRICAL SPINE, INC.LYQ00859373004074
Tensioner ClipGen 3EMPIRICAL SPINE, INC.LYQ00859373004067
PasserGen 3EMPIRICAL SPINE, INC.LYQ00859373004029