LORENZ STERNAL CLOSURE SYSTEM

Screw, Fixation, Bone

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Sternal Closure System.

Pre-market Notification Details

Device IDK033740
510k NumberK033740
Device Name:LORENZ STERNAL CLOSURE SYSTEM
ClassificationScrew, Fixation, Bone
Applicant WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville,  FL  32218
ContactKim Reed
CorrespondentKim Reed
WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville,  FL  32218
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-28
Decision Date2003-12-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841036079987 K033740 000
00841036078850 K033740 000
00841036078812 K033740 000
00841036075606 K033740 000
00841036075590 K033740 000
00841036074814 K033740 000

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