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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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