Cleared Traditional

XD880A Ultrasonic Osteotomy Surgical System

K172464 · Morley Research Consortium · Orthopedic

Apr 2018

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K172464 is an FDA 510(k) clearance for the XD880A Ultrasonic Osteotomy Surgical System, a Instrument, Surgical, Sonic And Accessory/attachment (Class II — Special Controls, product code JDX), submitted by Morley Research Consortium (Atlanta, US). The FDA issued a Cleared decision on April 24, 2018, 253 days after receiving the submission on August 14, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number	K172464 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2017
Decision Date	April 24, 2018
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF