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FDA 510(k)

Invictus Robotic Navigation Instruments

K-Number: K240951 · 2024-06-06

ApplicantAlphatec Spine
Decision Date2024-06-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Invictus Robotic Navigation Instruments is a medical device manufactured by Alphatec Spine. It received FDA 510(k) clearance on 2024-06-06 under approval number K240951. 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 Invictus Robotic Navigation Instruments?

Invictus Robotic Navigation Instruments is a medical device that received FDA 510(k) clearance on 2024-06-06. It is manufactured by Alphatec Spine. The 510(k) number is K240951.

When was Invictus Robotic Navigation Instruments approved by the FDA?

Invictus Robotic Navigation Instruments received FDA 510(k) clearance on 2024-06-06, under approval number K240951.

What company makes Invictus Robotic Navigation Instruments?

Invictus Robotic Navigation Instruments is manufactured by Alphatec Spine.

What is the FDA product code for Invictus Robotic Navigation Instruments?

The FDA product code for Invictus Robotic Navigation Instruments is OLO.

Related Clinical Trials

NCT07574762 Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery RECRUITING NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING NCT06308120 A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB ACTIVE_NOT_RECRUITING NCT05980442 Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty RECRUITING NCT06962436 RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs RECRUITING

Other Devices by Alphatec Spine

K160958Battalion Universal Spacer System K191185Solanas® Posterior OCT Fixation System K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer

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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