7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 Mm - 150 Mm, 7D Surgical Flex Array

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 Flashlock 1, 7d Surgical Flex Rod Connector - 5.5 Mm - 150 Mm, 7d Surgical Flex Array.

Pre-market Notification Details

Device IDK201966
510k NumberK201966
Device Name:7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 Mm - 150 Mm, 7D Surgical Flex Array
ClassificationOrthopedic Stereotaxic Instrument
Applicant 7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto,  CA M3b 2r7
ContactDaniel Zisind
CorrespondentDaniel Ziskind
7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto,  CA M3b 2r7
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-15
Decision Date2020-09-03

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