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FDA 510(k)

Harvey(R) Surgical Assistant

K-Number: K200892 · 2020-06-18

ApplicantOrthalign, Inc.
Decision Date2020-06-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Harvey(R) Surgical Assistant is a medical device manufactured by Orthalign, Inc.. It received FDA 510(k) clearance on 2020-06-18 under approval number K200892. 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 Harvey(R) Surgical Assistant?

Harvey(R) Surgical Assistant is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Orthalign, Inc.. The 510(k) number is K200892.

When was Harvey(R) Surgical Assistant approved by the FDA?

Harvey(R) Surgical Assistant received FDA 510(k) clearance on 2020-06-18, under approval number K200892.

What company makes Harvey(R) Surgical Assistant?

Harvey(R) Surgical Assistant is manufactured by Orthalign, Inc..

What is the FDA product code for Harvey(R) Surgical Assistant?

The FDA product code for Harvey(R) Surgical Assistant is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 40902105 Design of Automatic Tool Replacement Mechanism for Laparoscopic Surgical Robot Arm for Solo Surgery. The international journal of medical robotics + computer assisted surgery : MRCAS (2025)

Other Devices by Orthalign, Inc.

K153237OrthAlign Plus System K172462OrthAlign Plus System K171780OrthAlign Plus System K163379KneeAlign 2 System K162962OrthAlign Plus System K200642OrthAlign Plus System

View all 8 devices →

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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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