Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OrthAlign Plus System

K-Number: K200642 · 2020-04-10

ApplicantOrthalign, Inc.
Decision Date2020-04-10
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OrthAlign Plus System is the device name listed in this FDA 510(k) record. The listed applicant is Orthalign, Inc.. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K200642. 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 OrthAlign Plus System?

OrthAlign Plus System is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Orthalign, Inc.. The 510(k) number is K200642.

When did OrthAlign Plus System receive FDA 510(k) clearance?

OrthAlign Plus System received FDA 510(k) clearance on 2020-04-10, under 510(k) number K200642.

Who is the listed applicant for OrthAlign Plus System?

The FDA 510(k) record lists Orthalign, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthAlign Plus System?

The FDA product code for OrthAlign Plus System is OLO.

Other records listing Orthalign, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeK242616Lantern® HipK200892Harvey(R) Surgical AssistantK172462OrthAlign Plus SystemK171780OrthAlign Plus System

View all 10 devices →

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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.

↑