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FDA 510(k)

XD880A Ultrasonic Osteotomy Surgical System

K-Number: K172464 · 2018-04-24

ApplicantMorley Research Consortium
Decision Date2018-04-24
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XD880A Ultrasonic Osteotomy Surgical System is a medical device manufactured by Morley Research Consortium. It received FDA 510(k) clearance on 2018-04-24 under approval number K172464. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XD880A Ultrasonic Osteotomy Surgical System?

XD880A Ultrasonic Osteotomy Surgical System is a medical device that received FDA 510(k) clearance on 2018-04-24. It is manufactured by Morley Research Consortium. The 510(k) number is K172464.

When was XD880A Ultrasonic Osteotomy Surgical System approved by the FDA?

XD880A Ultrasonic Osteotomy Surgical System received FDA 510(k) clearance on 2018-04-24, under approval number K172464.

What company makes XD880A Ultrasonic Osteotomy Surgical System?

XD880A Ultrasonic Osteotomy Surgical System is manufactured by Morley Research Consortium.

What is the FDA product code for XD880A Ultrasonic Osteotomy Surgical System?

The FDA product code for XD880A Ultrasonic Osteotomy Surgical System is JDX.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (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)

Related Devices (Code: JDX)

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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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