Cleared Special

BonOs? Inject Bone Cement; NEO Pedicle Screw System?

K222256 · Neo Medical SA · Orthopedic

Aug 2022

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K222256 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 August 26, 2022, 30 days after receiving the submission on July 27, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K222256 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 2022
Decision Date	August 26, 2022
Days to Decision	30 days
Submission Type	Special
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.