Cleared Traditional

K180227 - Polaris Spinal Growth System
(FDA 510(k) Clearance)

K180227 · Zimmer Biomet Spine, Inc. · Orthopedic device

Mar 2018

Decision

48d

Days

Class 2

Risk

K180227 is an FDA 510(k) clearance for the Polaris Spinal Growth System. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).

Submitted by Zimmer Biomet Spine, Inc. (Westminister, US). The FDA issued a Cleared decision on March 15, 2018, 48 days after receiving the submission on January 26, 2018.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion..

Submission Details

510(k) Number	K180227 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 26, 2018
Decision Date	March 15, 2018
Days to Decision	48 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.