Cleared Traditional

OSCAR 3

K093805 · Orthosonics, Ltd. · Orthopedic

Feb 2010

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K093805 is an FDA 510(k) clearance for the OSCAR 3, a Instrument, Surgical, Sonic And Accessory/attachment (Class II — Special Controls, product code JDX), submitted by Orthosonics, Ltd. (Ashburton, Devon, GB). The FDA issued a Cleared decision on February 19, 2010, 70 days after receiving the submission on December 11, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number	K093805 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2009
Decision Date	February 19, 2010
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF