FDA.reportPublic FDA data

7D SURGICAL ULC

Matched from indexed company URL: 7D Surgical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
301209862930120986297D SURGICAL ULC1N2026-01-0160 Scarsdale Road, Unit 118 Toronto Ontario CA M3B 2R7

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2034921955279651K242480FLASH EVD System (10-0002)HAW2024-12-27
2034921788878452K2205227D Surgical System - Percutaneous Application (7D Flash Frame)OLO2022-05-20
2034921121118472K2105557D Surgical System - Drill GuideOLO2021-03-23
2034921284571004K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & KeyOLO2021-06-21
2034921490723661K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex ArrayOLO2020-09-03
2034921990404148K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement ApplicationHAW2019-11-27
2034921259830624K1921407D Surgical SystemOLO2019-11-05
2034921141514117K1832767D Surgical SystemHAW2019-08-07
2034921464034733K1810417D Surgical System Cranial ApplicationHAW2018-08-08
2034921542627887K1803527D Surgical SystemOLO2018-05-02
2034921513441296K162375Envision 3D: Image Guidance SystemOLO2016-12-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO72022-05-20
HAW42024-12-27

PMN#

GUDID#

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