Cleared Traditional

K150661 - ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite (FDA 510(k) Clearance)

K150661 · Citieffe S.R.L. · Orthopedic device

Jul 2015

Decision

116d

Days

Class 2

Risk

K150661 is an FDA 510(k) clearance for the ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Citieffe S.R.L. (Calderara Di Reno, IT). The FDA issued a Cleared decision on July 7, 2015, 116 days after receiving the submission on March 13, 2015.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K150661 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 13, 2015
Decision Date	July 07, 2015
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement