Cleared Traditional

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments

K153700 · Aesculap Implant Systems, LLC · Orthopedic

Jul 2016

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K153700 is an FDA 510(k) clearance for the Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on July 8, 2016, 198 days after receiving the submission on December 23, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K153700 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2015
Decision Date	July 08, 2016
Days to Decision	198 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.