SPIN DOWN RAPIDFLAP

Plate, Cranioplasty, Preformed, Non-alterable

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Spin Down Rapidflap.

Pre-market Notification Details

Device IDK031034
510k NumberK031034
Device Name:SPIN DOWN RAPIDFLAP
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
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 CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-01
Decision Date2003-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841036142049 K031034 000
00841036142032 K031034 000
00841036142025 K031034 000
00841036068028 K031034 000
00841036065492 K031034 000
00841036058586 K031034 000
00888233011273 K031034 000
00888233011259 K031034 000
00888233011235 K031034 000

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