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Vilex/Duval/Orthex Cannulated Bone Screw (P222-Xx +8 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K991197

by Vilex, Inc.

Identifiers

510(k) Number
K991197 FDA 510(k)
FDA Product Code
HWC FDA 510(k)
Models / Variants
P222-Xx FDA 510(k)
S25-Xx FDA 510(k)
P227-Xx FDA 510(k)
S30-Xx FDA 510(k)
P235-Xx FDA 510(k)
S35-Xx FDA 510(k)
P240-Xx FDA 510(k)
S40-Xx FDA 510(k)
P24 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 (P222-Xx +8 more) by Vilex, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 9 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vilex, Inc.

Sources (1)

  • FDA 510(k) K991197 24 fields · synced Jun 18, 2026