Cleared Traditional

K132636 - DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM (FDA 510(k) Clearance)

K132636 · Smith & Nephew, Inc. · Radiology device

Oct 2013

Decision

56d

Days

Class 2

Risk

K132636 is an FDA 510(k) clearance for the DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on October 17, 2013, 56 days after receiving the submission on August 22, 2013.

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

Submission Details

510(k) Number	K132636 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 22, 2013
Decision Date	October 17, 2013
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF