Cleared Traditional

The Progen? Trochanteric Nail System

K211086 · Ortho Development Corporation · Orthopedic
Dec 2021
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K211086 is an FDA 510(k) clearance for the The Progen? Trochanteric Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on December 21, 2021, 253 days after receiving the submission on April 12, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K211086 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2021
Decision Date December 21, 2021
Days to Decision 253 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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