7D Surgical System

Orthopedic Stereotaxic Instrument

7D Surgical Inc.

The following data is part of a premarket notification filed by 7d Surgical Inc. with the FDA for 7d Surgical System.

Pre-market Notification Details

Device IDK192140
501k NumberK192140
Device Name:7D Surgical System
ClassificationOrthopedic Stereotaxic Instrument
Applicant 7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto,  CA M3b 2r7
ContactDaniel Ziskind
CorrespondentDaniel Ziskind
7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto,  CA M3b 2r7
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-08
Decision Date2019-11-05

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