SPINE SCOPE, MODEL 2180

Arthroscope

CLARUS MEDICAL, LLC.

The following data is part of a premarket notification filed by Clarus Medical, Llc. with the FDA for Spine Scope, Model 2180.

Pre-market Notification Details

Device IDK011454
510k NumberK011454
Device Name:SPINE SCOPE, MODEL 2180
ClassificationArthroscope
Applicant CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH Minneapolis,  MN  55427
ContactTom Barthel
CorrespondentTom Barthel
CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH Minneapolis,  MN  55427
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-11
Decision Date2001-12-13

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