Cleared Special

LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM

K061384 · Walter Lorenz Surgical, Inc. · Orthopedic
Jun 2006
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K061384 is an FDA 510(k) clearance for the LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 6, 2006, 19 days after receiving the submission on May 18, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K061384 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2006
Decision Date June 06, 2006
Days to Decision 19 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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