LUQUE V SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

SOFAMOR DANEK MFG., INC.

The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Luque V Spinal System.

Pre-market Notification Details

Device IDK921256
510k NumberK921256
Device Name:LUQUE V SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis,  TN  38131
ContactRichard W Treharne
CorrespondentRichard W Treharne
SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis,  TN  38131
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-16
Decision Date1993-05-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00681490991209 K921256 000
00673978050980 K921256 000
00673978056258 K921256 000
00673978951683 K921256 000
00673978953199 K921256 000
00681490990769 K921256 000
00681490990783 K921256 000
00681490990820 K921256 000
00681490990844 K921256 000
00681490991018 K921256 000
00681490991063 K921256 000
00681490991117 K921256 000
00681490991124 K921256 000
00681490991155 K921256 000
00681490991193 K921256 000
00721902870408 K921256 000

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