Cleared Traditional

IMPLANET Spine System (ISS)

K143731 · Implanet, S.A. · Orthopedic

Apr 2015

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K143731 is an FDA 510(k) clearance for the IMPLANET Spine System (ISS), a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Implanet, S.A. (Martillac, FR). The FDA issued a Cleared decision on April 14, 2015, 106 days after receiving the submission on December 29, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K143731 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2014
Decision Date	April 14, 2015
Days to Decision	106 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.