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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 the device name listed in this FDA 510(k) record. The listed applicant is Intellijoint Surgical, Inc.. It received FDA 510(k) clearance on 2017-03-02 under 510(k) 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. The listed applicant is Intellijoint Surgical, Inc.. The 510(k) number is K162364.

When did Intellijoint HIP Generation 2A System receive FDA 510(k) clearance?

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

Who is the listed applicant for Intellijoint HIP Generation 2A System?

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

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

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

Other records listing Intellijoint Surgical, 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.

K211876Intellijoint VIEWK191507Intellijoint® Navigation SystemK172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument TrayK171525Intellijoint HIP Generation 2B System

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

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

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