METRX SYSTEM

Arthroscope

SURGICAL NAVIGATION TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Metrx System.

Pre-market Notification Details

Device IDK993021
510k NumberK993021
Device Name:METRX SYSTEM
ClassificationArthroscope
Applicant SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield,  CO  80020
ContactRoger N White
CorrespondentRoger N White
SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield,  CO  80020
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-08
Decision Date1999-11-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00673978085609 K993021 000
00673978085593 K993021 000
00673978085524 K993021 000
00673978085517 K993021 000
00673978085487 K993021 000
00673978085456 K993021 000
00721902949180 K993021 000
00721902663444 K993021 000
00721902444104 K993021 000

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