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FDA 510(k)

PROPHECY INVISION Preoperative Navigation Alignment System

K-Number: K162795 · 2017-02-22

ApplicantWrightmedicaltechnologyinc
Decision Date2017-02-22
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROPHECY INVISION Preoperative Navigation Alignment System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-02-22 under approval number K162795. 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 Preoperative Navigation Alignment System?

PROPHECY INVISION Preoperative Navigation Alignment System is a medical device that received FDA 510(k) clearance on 2017-02-22. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K162795.

When was PROPHECY INVISION Preoperative Navigation Alignment System approved by the FDA?

PROPHECY INVISION Preoperative Navigation Alignment System received FDA 510(k) clearance on 2017-02-22, under approval number K162795.

What company makes PROPHECY INVISION Preoperative Navigation Alignment System?

PROPHECY INVISION Preoperative Navigation Alignment System is manufactured by Wrightmedicaltechnologyinc.

What is the FDA product code for PROPHECY INVISION Preoperative Navigation Alignment System?

The FDA product code for PROPHECY INVISION Preoperative Navigation Alignment System is HSN.

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Related PubMed Literature

PMID: 40866856 Prognostic value of nutritional risk assessment indices in patients with digestive system tumors. BMC cancer (2025) 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) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Wrightmedicaltechnologyinc

K152062BIOFOAM Bone Wedge K153008INVISION Total Ankle Revision System K153635SALVATION(R) External Fixation System K171852DARCO Locking Bone Plate System K171067INVISION Total Ankle Revision System K170642GRAVITY™ Soft Tissue Repair System

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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 K170968PROPHECY INVISION Pre-operative Navigation 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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