RECONSTRUCTION PLATE SYSTEM

Plate, Fixation, Bone

SOFAMOR DANEK MFG., INC.

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

Pre-market Notification Details

Device IDK924085
510k NumberK924085
Device Name:RECONSTRUCTION PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis,  TN  38131
ContactBailey Lipscomb
CorrespondentBailey Lipscomb
SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis,  TN  38131
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-13
Decision Date1992-12-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00721902815522 K924085 000
00885074525884 K924085 000

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