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Tiger Spine System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110321

by Corelink Llc

Identifiers

510(k) Number
K110321 FDA 510(k)
FDA Product Code
MNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Tiger Spine 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) K110321 24 fields · synced Jun 18, 2026