Skip to content

Crossnav Navigation Enabled Instruments

by DePuy Synthes 510(k)

Active United States

510(k) K233255

Overview

The Crossnav Navigation Enabled Instruments are reusable orthopedic surgical tools designed for spinal procedures. These instruments assist surgeons in accurately locating anatomical structures during the preparation and placement of DePuy Synthes screws, applicable to both open and percutaneous techniques.

Intended for use exclusively with specific DePuy Synthes implant systems, these instruments are cleared under FDA 510(k) clearance number K233255. They fall under product code OLO and are classified as a Class 2 device, regulated through the Traditional 510(k) pathway. The instruments are reusable and require compatibility with the manufacturer’s navigation system for precise surgical guidance.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233255 Date17 Jun 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from DePuy Synthes

See all devices from DePuy Synthes →

Questions

  • Are these instruments compatible with any spinal implant system, or only specific DePuy Synthes systems?

    These instruments are designed exclusively for use with specific DePuy Synthes implant systems. They rely on the manufacturer’s navigation system for precise guidance, so compatibility is limited to those systems approved for use with Crossnav technology.

  • How are these instruments classified and what regulatory pathway was used for FDA clearance?

    The Crossnav Navigation Enabled Instruments are classified as a Class 2 device under FDA regulations. They were cleared through the Traditional 510(k) pathway, with a clearance number of K233255, and fall under product code OLO. The submission was reviewed by the Orthopaedic Devices Panel (OR).

  • Can these instruments be reused in multiple surgeries, or are they intended for single-use only?

    These instruments are explicitly designed for reuse. They are not intended for single-use and must be properly cleaned and maintained between procedures to ensure accuracy and sterility for subsequent surgeries.

  • What type of surgical procedures are these instruments intended to assist with?

    The instruments are intended for spinal procedures, specifically to assist surgeons in accurately locating anatomical structures during the preparation and placement of DePuy Synthes screws. They support both open and percutaneous techniques.

  • Do these instruments require any additional equipment or software to function properly?

    Yes, these instruments require compatibility with DePuy Synthes’ navigation system for precise surgical guidance. The navigation system is essential for their functionality and accuracy during spinal procedures.