SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)

Appliance, Fixation, Spinal Intervertebral Body

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes(usa)titanium Locking Plate System(tilps).

Pre-market Notification Details

Device IDK970048
510k NumberK970048
Device Name:SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-06
Decision Date1997-08-01
Summary:summary

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