Cleared Traditional

FLOSPINE PEDICLE SCREW SYSTEM

K141850 · Flospine · Orthopedic

Oct 2014

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K141850 is an FDA 510(k) clearance for the FLOSPINE PEDICLE SCREW SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Flospine (Fr. Myers, US). The FDA issued a Cleared decision on October 27, 2014, 110 days after receiving the submission on July 9, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K141850 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2014
Decision Date	October 27, 2014
Days to Decision	110 days
Submission Type	Traditional
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.