Cleared Traditional

LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER

K030425 · Walter Lorenz Surgical, Inc. · Dental
May 2004
Decision
459d
Days
Class 2
Risk

About This 510(k) Submission

K030425 is an FDA 510(k) clearance for the LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 14, 2004, 459 days after receiving the submission on February 10, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K030425 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2003
Decision Date May 14, 2004
Days to Decision 459 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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