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F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and O…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231743

by Corelink Llc

Identifiers

510(k) Number
K231743 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and O… by Corelink Llc — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Corelink Llc
FDA Applicant
Corelink, LLC

Sources (1)

  • FDA 510(k) K231743 24 fields · synced Jun 19, 2026