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CoreLink F3D™ Lateral System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183239

by Corelink Llc

Identifiers

510(k) Number
K183239 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)

CoreLink F3D™ Lateral System by Corelink Llc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

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) K183239 24 fields · synced Jun 18, 2026