Cleared Traditional

Daytona? Small Stature Growth Rod Conversion Set

K193224 · SeaSpine Orthopedics Corporation · Orthopedic
Feb 2020
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K193224 is an FDA 510(k) clearance for the Daytona? Small Stature Growth Rod Conversion Set, a Growing Rod System (Class II — Special Controls, product code PGM), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 13, 2020, 83 days after receiving the submission on November 22, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K193224 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2019
Decision Date February 13, 2020
Days to Decision 83 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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