Cleared Traditional

K142648 - SPINEDESIGN Spine Surgery Planning (Software Application) (FDA 510(k) Clearance)

K142648 · Medtronic Sofamor Danek USA, Inc. · Radiology device

May 2015

Decision

247d

Days

Class 2

Risk

K142648 is an FDA 510(k) clearance for the SPINEDESIGN Spine Surgery Planning (Software Application). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on May 22, 2015, 247 days after receiving the submission on September 17, 2014.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K142648 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 17, 2014
Decision Date	May 22, 2015
Days to Decision	247 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF