Cleared Traditional

LORENZ SELF DRILLING SCREWS

K013954 · Walter Lorenz Surgical, Inc. · Orthopedic
Feb 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K013954 is an FDA 510(k) clearance for the LORENZ 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 February 28, 2002, 90 days after receiving the submission on November 30, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K013954 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2001
Decision Date February 28, 2002
Days to Decision 90 days
Submission Type Traditional
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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