Cleared Special

OSCAR, MODEL OE3000

K021502 · Orthosonics, Ltd. · Orthopedic

Jun 2002

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K021502 is an FDA 510(k) clearance for the OSCAR, MODEL OE3000, a System, Cement Removal Extraction (Class II — Special Controls, product code LZV), submitted by Orthosonics, Ltd. (Brookeville, US). The FDA issued a Cleared decision on June 6, 2002, 28 days after receiving the submission on May 9, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number	K021502 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2002
Decision Date	June 06, 2002
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF