Cleared Traditional

K013616 - POLARUS CAP SCREW
(FDA 510(k) Clearance)

K013616 · Acu Med, Inc. · Orthopedic

Dec 2001

Decision

44d

Days

Class 2

Risk

K013616 is an FDA 510(k) clearance for the POLARUS CAP SCREW, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on December 19, 2001, 44 days after receiving the submission on November 5, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K013616 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2001
Decision Date	December 19, 2001
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF