Cleared Traditional

BonOs Inject Bone Cement; NEO Pedicle Screw System

K212489 · Neo Medical SA · Orthopedic

Oct 2021

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K212489 is an FDA 510(k) clearance for the BonOs Inject Bone Cement; NEO Pedicle Screw System, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Neo Medical SA (Villette (Lavaux), CH). The FDA issued a Cleared decision on October 28, 2021, 80 days after receiving the submission on August 9, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K212489 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2021
Decision Date	October 28, 2021
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PML — Bone Cement, Posterior Screw Augmentation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3027
Definition	The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.