Cleared Special

APCLO PEDICLE SCREW SYSTEMS

K112759 · Atlas Spine, Inc. · Orthopedic

Oct 2011

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K112759 is an FDA 510(k) clearance for the APCLO PEDICLE SCREW SYSTEMS, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on October 18, 2011, 26 days after receiving the submission on September 22, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K112759 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2011
Decision Date	October 18, 2011
Days to Decision	26 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.