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

FDA 510(k)

PathKeeper System

K-Number: K222355 · 2023-03-08

ApplicantPathkeeper Surgical , Ltd.
Decision Date2023-03-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PathKeeper System is a medical device manufactured by Pathkeeper Surgical , Ltd.. It received FDA 510(k) clearance on 2023-03-08 under approval number K222355. 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 PathKeeper System?

PathKeeper System is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Pathkeeper Surgical , Ltd.. The 510(k) number is K222355.

When was PathKeeper System approved by the FDA?

PathKeeper System received FDA 510(k) clearance on 2023-03-08, under approval number K222355.

What company makes PathKeeper System?

PathKeeper System is manufactured by Pathkeeper Surgical , Ltd..

What is the FDA product code for PathKeeper System?

The FDA product code for PathKeeper System is OLO.

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.

↑