Cleared Traditional

Curiteva Navigation System

K223200 · Curiteva, Inc. · Orthopedic
Jan 2023
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K223200 is an FDA 510(k) clearance for the Curiteva Navigation System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on January 6, 2023, 85 days after receiving the submission on October 13, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K223200 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2022
Decision Date January 06, 2023
Days to Decision 85 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.

Similar Devices — OLO Orthopedic Stereotaxic Instrument

All 414
TMINI? Miniature Robotic System
K260010 · THINK Surgical, Inc. · Mar 2026
Mako Total Knee Application
K260222 · Mako Surgical Corp. · Feb 2026
?POINT? Kinguide Agile Hybrid Navigation System; DRF Accessories Set
K252989 · Point Robotics MedTech, Inc. · Feb 2026
Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
K252597 · Alphatec Spine, Inc. · Feb 2026
Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
K253623 · Stryker Leibinger GmbH & Co KG · Feb 2026
VERTICALE GPS Instruments
K254148 · Silony Medical GmbH · Feb 2026

More from Curiteva, Inc.

View all
Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
K252205 · ODP · Jan 2026
Curiteva Porous PEEK Cervical Interbody Fusion System
K254061 · ODP · Jan 2026
Curiteva Porous PEEK Standalone ALIF System
K250845 · OVD · Jun 2025
Curiteva Porous PEEK Laminoplasty System
K243137 · NQW · Oct 2024
Curiteva Thoracolumbar Plate System
K233360 · KWQ · Feb 2024