FDA 510(k) Applications Submitted by 7D SURGICAL INC.

FDA 510(k) Number Submission Date Device Name Applicant
K210457 02/16/2021 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key 7D Surgical Inc.
K210555 02/25/2021 7D Surgical System - Drill Guide 7D Surgical Inc.
K201966 07/15/2020 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array 7D Surgical Inc.
K192945 10/18/2019 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application 7D Surgical Inc.
K180352 02/08/2018 7D Surgical System 7D Surgical Inc.
K181041 04/19/2018 7D Surgical System Cranial Application 7D Surgical Inc.
K192140 08/08/2019 7D Surgical System 7D Surgical Inc.
K162375 08/24/2016 Envision 3D: Image Guidance System 7D SURGICAL INC.
K183276 11/23/2018 7D Surgical System 7D Surgical Inc.


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