SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Spine Universal Spinal Hook, Rod, Pedicle/sacral Screw Fixation System.

Pre-market Notification Details

Device IDK980928
510k NumberK980928
Device Name:SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
ContactBarry E Sands
CorrespondentBarry E Sands
SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-11
Decision Date1998-05-11
Summary:summary

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