Cleared Traditional

K183544 - Efficient Care 3D Planning (FDA 510(k) Clearance)

K183544 · Orthosoft Inc. (d/b/a) Zimmer CAS · Radiology device

Aug 2019

Decision

246d

Days

Class 2

Risk

K183544 is an FDA 510(k) clearance for the Efficient Care 3D Planning. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Orthosoft Inc. (d/b/a) Zimmer CAS (Montreal, CA). The FDA issued a Cleared decision on August 23, 2019, 246 days after receiving the submission on December 20, 2018.

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

Submission Details

510(k) Number	K183544 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 20, 2018
Decision Date	August 23, 2019
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF