Cleared Special

K033740 - LORENZ STERNAL CLOSURE SYSTEM
(FDA 510(k) Clearance)

K033740 · Walter Lorenz Surgical, Inc. · Orthopedic

Dec 2003

Decision

17d

Days

Class 2

Risk

K033740 is an FDA 510(k) clearance for the LORENZ STERNAL CLOSURE SYSTEM, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on December 15, 2003, 17 days after receiving the submission on November 28, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K033740 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2003
Decision Date	December 15, 2003
Days to Decision	17 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF