Cleared Traditional

DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM

K140038 · Curexo Technology Corporation · Orthopedic
May 2014
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K140038 is an FDA 510(k) clearance for the DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM, a Orthopedic Computer Controlled Surgical System (Class II — Special Controls, product code OJP), submitted by Curexo Technology Corporation (Melrose, US). The FDA issued a Cleared decision on May 27, 2014, 140 days after receiving the submission on January 7, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K140038 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2014
Decision Date May 27, 2014
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OJP — Orthopedic Computer Controlled Surgical System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition Pre-operative Planning And Intra-operative Execution Of Surgical Movements With Robotically Controlled End Effectors Under User Supervision. Alternative To Manual Planning And Broaching/reaming Techniques For Femoral Canal Preparation In Primary Total Hip Arthroplasty (tha).