Cleared Traditional

OSCAR, MODEL OE3000DB

K051053 · Orthosonics, Ltd. · Orthopedic

Jul 2005

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K051053 is an FDA 510(k) clearance for the OSCAR, MODEL OE3000DB, a Instrument, Surgical, Sonic And Accessory/attachment (Class II — Special Controls, product code JDX), submitted by Orthosonics, Ltd. (Brookeville, US). The FDA issued a Cleared decision on July 21, 2005, 87 days after receiving the submission on April 25, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number	K051053 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2005
Decision Date	July 21, 2005
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF