XD880A Ultrasonic Osteotomy Surgical System— 510(k) K172464

Name: FDA 510(k) clearance K172464
Creator: U.S. Food and Drug Administration
Published: 2018-04-24

Substantially Equivalent

Morley Research Consortium

FDA 510(k) clearance K172464 for XD880A Ultrasonic Osteotomy Surgical System, Substantially Equivalent on 2018-04-24. Applicant: Morley Research Consortium. Device class: 2.

Clearance details

Applicant: Morley Research Consortium
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2017-08-14
Decision date: 2018-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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