T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

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 T-pal Spacer System, T-pal Titanium Spacer System, Synfix Evolution System.

Pre-market Notification Details

Device IDK162358
510k NumberK162358
Device Name:T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SYNTHES USA PRODUCTS LLC 325 Paramount Drive Raynham,  MA  02767
ContactEugene Bang
CorrespondentEugene Bang
SYNTHES USA PRODUCTS LLC 325 Paramount Drive Raynham,  MA  02767
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-23
Decision Date2016-11-01
Summary:summary

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