Cleared Special

S4 SPINAL SYSTEM

K062085 · Aesculap · Orthopedic

Mar 2007

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K062085 is an FDA 510(k) clearance for the S4 SPINAL SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on March 2, 2007, 224 days after receiving the submission on July 21, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K062085 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2006
Decision Date	March 02, 2007
Days to Decision	224 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.