Cleared Traditional

AEQUALIS HUMERAL NAIL SYSTEM

K082754 · Tornier · Orthopedic
Jan 2009
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K082754 is an FDA 510(k) clearance for the AEQUALIS HUMERAL NAIL SYSTEM, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Tornier (Warsaw, US). The FDA issued a Cleared decision on January 27, 2009, 130 days after receiving the submission on September 19, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K082754 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2008
Decision Date January 27, 2009
Days to Decision 130 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

Similar Devices — HSB Rod, Fixation, Intramedullary And Accessories

All 519
Affixus Retrograde Femoral Nailing System
K253566 · Zimmer, Inc. · Mar 2026
Reselute Tibial Nail
K253517 · Reselute, Inc. · Mar 2026
Arthrex FibuLock Nail System
K252196 · Arthrex, Inc. · Mar 2026
Phantom? Hindfoot TTC/TC Nail System
K253591 · Paragon 28, Inc. · Mar 2026
Active Intramedullary (AIM) Tibial Nail System
K252025 · Satori Orthopaedics, Inc. · Mar 2026
T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
K253640 · Stryker GmbH · Feb 2026