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FDA 510(k)

Intellijoint HIP Generation 2A System

K-Number: K162364 · 2017-03-02

ApplicantIntellijoint Surgical, Inc.
Decision Date2017-03-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Intellijoint HIP Generation 2A System is a medical device manufactured by Intellijoint Surgical, Inc.. It received FDA 510(k) clearance on 2017-03-02 under approval number K162364. 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 Intellijoint HIP Generation 2A System?

Intellijoint HIP Generation 2A System is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by Intellijoint Surgical, Inc.. The 510(k) number is K162364.

When was Intellijoint HIP Generation 2A System approved by the FDA?

Intellijoint HIP Generation 2A System received FDA 510(k) clearance on 2017-03-02, under approval number K162364.

What company makes Intellijoint HIP Generation 2A System?

Intellijoint HIP Generation 2A System is manufactured by Intellijoint Surgical, Inc..

What is the FDA product code for Intellijoint HIP Generation 2A System?

The FDA product code for Intellijoint HIP Generation 2A System is OLO.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT07593625 Evaluating Glucose Control Using a Next-Generation AID Algorithm in Adults With T1D NOT_YET_RECRUITING NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING NCT05110183 Opto-electrical Cochlear Implants ENROLLING_BY_INVITATION NCT05867927 GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications RECRUITING NCT05498376 The Leadless AV Versus DDD Pacing Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025)

Other Devices by Intellijoint Surgical, Inc.

K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray K171525Intellijoint HIP Generation 2B System K191507Intellijoint® Navigation System K211876Intellijoint VIEW

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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