Cleared Traditional

Navigation Tracking Instruments

K232800 · SI-BONE, Inc. · Orthopedic

Feb 2024

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K232800 is an FDA 510(k) clearance for the Navigation Tracking Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on February 23, 2024, 164 days after receiving the submission on September 12, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K232800 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 2023
Decision Date	February 23, 2024
Days to Decision	164 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.