Cleared Special

MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS

K040990 · Walter Lorenz Surgical, Inc. · General & Plastic Surgery
May 2004
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K040990 is an FDA 510(k) clearance for the MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS, a Marker, Radiographic, Implantable (Class II — Special Controls, product code NEU), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 13, 2004, 27 days after receiving the submission on April 16, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K040990 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2004
Decision Date May 13, 2004
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code NEU — Marker, Radiographic, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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