Cleared Special

LORENZ 2.4 SELF DRILLING SCREWS

K032228 · Walter Lorenz Surgical, Inc. · Orthopedic
Aug 2003
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K032228 is an FDA 510(k) clearance for the LORENZ 2.4 SELF DRILLING SCREWS, 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 August 11, 2003, 21 days after receiving the submission on July 21, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K032228 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2003
Decision Date August 11, 2003
Days to Decision 21 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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