FALCON SPACER

Intervertebral Fusion Device With Bone Graft, Lumbar

SYNTHES (USA) PRODUCTS LLC

The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Falcon Spacer.

Pre-market Notification Details

Device IDK123180
510k NumberK123180
Device Name:FALCON SPACER
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactMonika Mcdole-russell
CorrespondentMonika Mcdole-russell
SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-10
Decision Date2013-01-08
Summary:summary

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