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FDA 510(k)

PROPHECY INVISION Pre-operative Navigation System

K-Number: K170968 · 2017-08-16

ApplicantWrightmedicaltechnologyinc
Decision Date2017-08-16
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROPHECY INVISION Pre-operative Navigation System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-08-16 under approval number K170968. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPHECY INVISION Pre-operative Navigation System?

PROPHECY INVISION Pre-operative Navigation System is a medical device that received FDA 510(k) clearance on 2017-08-16. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K170968.

When was PROPHECY INVISION Pre-operative Navigation System approved by the FDA?

PROPHECY INVISION Pre-operative Navigation System received FDA 510(k) clearance on 2017-08-16, under approval number K170968.

What company makes PROPHECY INVISION Pre-operative Navigation System?

PROPHECY INVISION Pre-operative Navigation System is manufactured by Wrightmedicaltechnologyinc.

What is the FDA product code for PROPHECY INVISION Pre-operative Navigation System?

The FDA product code for PROPHECY INVISION Pre-operative Navigation System is HSN.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Wrightmedicaltechnologyinc

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Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc

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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