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Vilex/Duval/Orthex Cannulated Bone Screw Db1 Thread, Model F25-Xx-09 +1 more mo…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K014154

by Vilex, Inc.

Identifiers

510(k) Number
K014154 FDA 510(k)
FDA Product Code
HWC FDA 510(k)
Models / Variants
Vilex/Duval/Orthex Cannulated Bone Screw Db1 Thread, Model F25-Xx-09 FDA 510(k)
Vilex Solid Bone Screws Db1 Thread, Model F20-Xx-00 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Vilex/Duval/Orthex Cannulated Bone Screw Db1 Thread, Model F25-Xx-09 +1 more mo… by Vilex, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vilex, Inc.

Sources (1)

  • FDA 510(k) K014154 24 fields · synced Jun 18, 2026