Cleared Traditional

OSCAR BONE RESECTOR

K083830 · Orthosonics, Ltd. · Orthopedic

Mar 2009

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K083830 is an FDA 510(k) clearance for the OSCAR BONE RESECTOR, 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 March 20, 2009, 87 days after receiving the submission on December 23, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number	K083830 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2008
Decision Date	March 20, 2009
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF