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Linkt Compression Staple System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250712

by Trax Surgical

Identifiers

510(k) Number
K250712 FDA 510(k)
FDA Product Code
JDR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Linkt Compression Staple System by Trax Surgical — 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
Trax Surgical

Sources (1)

  • FDA 510(k) K250712 24 fields · synced Jun 19, 2026