7D Surgical System Drill Guide

510(k) Number

K210555 ↗

FDA Product Code

OLO

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key

  Class II

  FDA 510(k) K210457 Active Cleared 21 Jun 2021

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

  Class II

  FDA 510(k) K201966 Active Cleared 3 Sep 2020

• 7D Surgical System Cranial Application

  Class II

  FDA 510(k) K181041 Active Cleared 8 Aug 2018

• 7D Surgical System - Percutaneous Application (7D Flash Frame)

  Class II

  FDA 510(k) K220522 Active Cleared 20 May 2022

• 7D Surgical System

  Class II

  FDA 510(k) K192140 Active Cleared 5 Nov 2019

• 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

  Class II

  FDA 510(k) K192945 Active Cleared 27 Nov 2019

See all devices from 7D Surgical, Inc. →

• What is the 7D Surgical System Drill Guide used for?

  The 7D Surgical System Drill Guide is designed for neurosurgical and spinal applications requiring precise positioning of probes, drills, or orthopedic tools within the nervous system. Its rigid frame and calibrated guide mechanism enhance accuracy during cranial or spinal procedures, ensuring safe and targeted instrument placement.

• Is the 7D Drill Guide reusable or single-use?

  The 7D Surgical System Drill Guide is supplied as a reusable surgical instrument. It must be cleaned and sterilized according to standard facility protocols before each use to maintain sterility and functionality in sterile operating room environments.

• What configurations or models are available for the 7D Drill Guide?

  The device is available in configurations compatible with the Medtronic Universal Drill Guide, ensuring seamless integration with existing orthopedic drilling systems. Specific model variations may align with common neurosurgical and spinal procedure requirements, but compatibility with standard systems is a key feature.

• How should the 7D Drill Guide be stored?

  Storage follows standard surgical instrument protocols, including proper cleaning and sterilization procedures as dictated by the facility’s guidelines. The device must be kept in a clean, dry environment to prevent contamination and ensure readiness for reuse in sterile operating conditions.

• Is the 7D Drill Guide compatible with MRI-safe systems?

  Yes, the 7D Surgical System Drill Guide is explicitly designed to be compatible with MRI-safe drilling systems. This compatibility is critical for procedures requiring intraoperative imaging, as it minimizes interference and ensures safety during MRI-guided surgeries.