Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PROPHECY Preoperative Navigation Alignment System

K-Number: K202815 · 2021-03-10

ApplicantWrightmedicaltechnologyinc
Decision Date2021-03-10
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROPHECY Preoperative Navigation Alignment System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2021-03-10 under approval number K202815. 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 Preoperative Navigation Alignment System?

PROPHECY Preoperative Navigation Alignment System is a medical device that received FDA 510(k) clearance on 2021-03-10. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K202815.

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

PROPHECY Preoperative Navigation Alignment System received FDA 510(k) clearance on 2021-03-10, under approval number K202815.

What company makes PROPHECY Preoperative Navigation Alignment System?

PROPHECY Preoperative Navigation Alignment System is manufactured by Wrightmedicaltechnologyinc.

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

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

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING 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

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

View all 37 devices →

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.

↑