AXIAL AND OFFSET CROSSLINK PLATES

Appliance, Fixation, Spinal Interlaminal

DANEK MEDICAL, INC.

The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Axial And Offset Crosslink Plates.

Pre-market Notification Details

Device IDK896740
510k NumberK896740
Device Name:AXIAL AND OFFSET CROSSLINK PLATES
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis,  TN  38131
ContactFrank M Lewis
CorrespondentFrank M Lewis
DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis,  TN  38131
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-30
Decision Date1990-02-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00673978047232 K896740 000
00673978047225 K896740 000
00673978047188 K896740 000

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