Cleared Special

SPIN DOWN RAPIDFLAP

K031034 · Walter Lorenz Surgical, Inc. · Neurology
May 2003
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K031034 is an FDA 510(k) clearance for the SPIN DOWN RAPIDFLAP, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 21, 2003, 50 days after receiving the submission on April 1, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K031034 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2003
Decision Date May 21, 2003
Days to Decision 50 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXN — Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5330

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