Cleared Traditional

K2M Growing Spine System

K161028 · K2m, Inc. · Orthopedic
Jul 2016
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K161028 is an FDA 510(k) clearance for the K2M Growing Spine System, a Growing Rod System (Class II — Special Controls, product code PGM), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on July 22, 2016, 101 days after receiving the submission on April 12, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K161028 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2016
Decision Date July 22, 2016
Days to Decision 101 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code PGM — Growing Rod System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070
Definition Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.

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