Cleared Traditional

VERTICALE Navigation Instruments

K212007 · Silony Medical GmbH · Orthopedic

Aug 2021

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K212007 is an FDA 510(k) clearance for the VERTICALE Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Silony Medical GmbH (Leinfelden-Echterdingen, DE). The FDA issued a Cleared decision on August 12, 2021, 45 days after receiving the submission on June 28, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K212007 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2021
Decision Date	August 12, 2021
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.