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FDA 510(k)

7D Surgical System - Drill Guide

K-Number: K210555 · 2021-03-23

Applicant7D Surgical, Inc.
Decision Date2021-03-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

7D Surgical System - Drill Guide is a medical device manufactured by 7D Surgical, Inc.. It received FDA 510(k) clearance on 2021-03-23 under approval number K210555. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7D Surgical System - Drill Guide?

7D Surgical System - Drill Guide is a medical device that received FDA 510(k) clearance on 2021-03-23. It is manufactured by 7D Surgical, Inc.. The 510(k) number is K210555.

When was 7D Surgical System - Drill Guide approved by the FDA?

7D Surgical System - Drill Guide received FDA 510(k) clearance on 2021-03-23, under approval number K210555.

What company makes 7D Surgical System - Drill Guide?

7D Surgical System - Drill Guide is manufactured by 7D Surgical, Inc..

What is the FDA product code for 7D Surgical System - Drill Guide?

The FDA product code for 7D Surgical System - Drill Guide is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by 7D Surgical, Inc.

K162375Envision 3D: Image Guidance System K1810417D Surgical System Cranial Application K1803527D Surgical System K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application K1921407D Surgical System K1832767D Surgical System

View all 9 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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