DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM

Orthopedic Computer Controlled Surgical System

CUREXO TECHNOLOGY CORPORATION

The following data is part of a premarket notification filed by Curexo Technology Corporation with the FDA for Digimatch Orthodoc Robodoc Encore Surgical System.

Pre-market Notification Details

Device IDK140038
510k NumberK140038
Device Name:DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
ClassificationOrthopedic Computer Controlled Surgical System
Applicant CUREXO TECHNOLOGY CORPORATION 32 HARRISON ST. Melrose,  MA  02176
ContactGlen Emelock
CorrespondentGlen Emelock
CUREXO TECHNOLOGY CORPORATION 32 HARRISON ST. Melrose,  MA  02176
Product CodeOJP  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-07
Decision Date2014-05-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.