Cleared Traditional

LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES

K063052 · Walter Lorenz Surgical, Inc. · Dental
Jan 2007
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K063052 is an FDA 510(k) clearance for the LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES, 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 January 12, 2007, 100 days after receiving the submission on October 4, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K063052 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2006
Decision Date January 12, 2007
Days to Decision 100 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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