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Digimatch Orthodoc Robodoc Encore Surgical System

by Curexo Technology Corporation 510(k)

Active United States

510(k) K140038

Overview

The Digimatch Orthodoc Robodoc Encore Surgical System is an Orthopedic Computer Controlled Surgical System. It is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures.

The system is supplied as a surgical planning and intraoperative guidance system. It is regulated under FDA 510(k) clearance K140038, product code OJP, and classified as a Class II device with regulation number 882.4560. The device is used in a neurology medical specialty setting.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140038 Date27 May 2014ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

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

Other devices from Curexo Technology Corporation

Questions

  • What is the Digimatch Orthodoc Robodoc Encore Surgical System used for?

    The system is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures.

  • How is the Digimatch Orthodoc Robodoc Encore Surgical System supplied?

    The system is supplied as a surgical planning and intraoperative guidance system.

  • What regulatory pathway was used for the Digimatch Orthodoc Robodoc Encore Surgical System?

    The device is regulated under FDA 510(k) clearance K140038, product code OJP, and classified as a Class II device with regulation number 882.4560.

  • In which medical specialty setting is the Digimatch Orthodoc Robodoc Encore Surgical System used?

    The device is used in a neurology medical specialty setting.