Cleared Traditional

Robotic Graft Delivery Instruments

K230716 · Medtronic Sofamor Danek, Inc. · Orthopedic

Jul 2023

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K230716 is an FDA 510(k) clearance for the Robotic Graft Delivery Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on July 18, 2023, 125 days after receiving the submission on March 15, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K230716 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2023
Decision Date	July 18, 2023
Days to Decision	125 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.