Cleared Traditional

Robotic Integration Instruments

K233256 · DePuy Synthes · Orthopedic

Jun 2024

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K233256 is an FDA 510(k) clearance for the Robotic Integration Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by DePuy Synthes (Oberdor, CH). The FDA issued a Cleared decision on June 17, 2024, 263 days after receiving the submission on September 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K233256 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	June 17, 2024
Days to Decision	263 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.