Cleared Special

K091121 - ORTHOSTAT (FDA 510(k) Clearance)

K091121 · Orthocon, Inc. · General & Plastic Surgery device

Apr 2009

Decision

11d

Days

—

Risk

K091121 is an FDA 510(k) clearance for the ORTHOSTAT. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (North Brunswick, US). The FDA issued a Cleared decision on April 28, 2009, 11 days after receiving the submission on April 17, 2009.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K091121 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 17, 2009
Decision Date	April 28, 2009
Days to Decision	11 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF