Cleared Traditional

K011076 - LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
(FDA 510(k) Clearance)

K011076 · Walter Lorenz Surgical, Inc. · Orthopedic

Jul 2001

Decision

98d

Days

Class 2

Risk

K011076 is an FDA 510(k) clearance for the LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 16, 2001, 98 days after receiving the submission on April 9, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K011076 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2001
Decision Date	July 16, 2001
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF