Discectomy Navigation Ready Instruments And Universal Navigation Adaptor Set

Orthopedic Stereotaxic Instrument

MEDOS International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Discectomy Navigation Ready Instruments And Universal Navigation Adaptor Set.

Pre-market Notification Details

Device IDK212756
510k NumberK212756
Device Name:Discectomy Navigation Ready Instruments And Universal Navigation Adaptor Set
ClassificationOrthopedic Stereotaxic Instrument
Applicant MEDOS International SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactNicole Aeschbacher
CorrespondentNicole Aeschbacher
MEDOS International SARL Chemin-Blanc 38 Le Locle,  CH 2400
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-31
Decision Date2022-05-05

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