TSRH CENTRAL POST HOOKS

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 Tsrh Central Post Hooks.

Pre-market Notification Details

Device IDK914966
510k NumberK914966
Device Name:TSRH CENTRAL POST HOOKS
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 (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-05
Decision Date1992-05-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00673978039398 K914966 000

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