Cleared Traditional

K260390 - Super Upper Limbs Versalock Plating System (FDA 510(k) Clearance)

Mar 2026
Decision
39d
Days
Risk

K260390 is an FDA 510(k) clearance for the Super Upper Limbs Versalock Plating System..

Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on March 17, 2026, 39 days after receiving the submission on February 6, 2026.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number K260390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2026
Decision Date March 17, 2026
Days to Decision 39 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code
Device Class