Cleared Traditional

NILE Proximal Fixation Spinal System

K161332 · K2m, Inc. · Orthopedic

Apr 2017

Decision

328d

Days

Class 2

Risk

About This 510(k) Submission

K161332 is an FDA 510(k) clearance for the NILE Proximal Fixation Spinal System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on April 5, 2017, 328 days after receiving the submission on May 12, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K161332 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2016
Decision Date	April 05, 2017
Days to Decision	328 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWI — Bone Fixation Cerclage, Sublaminar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3010
Definition	Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.