SCIENT'X TRIBECA VBR

Intervertebral Fusion Device With Bone Graft, Lumbar

SCIENT'X USA, INC.

The following data is part of a premarket notification filed by Scient'x Usa, Inc. with the FDA for Scient'x Tribeca Vbr.

Pre-market Notification Details

Device IDK080588
510k NumberK080588
Device Name:SCIENT'X TRIBECA VBR
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SCIENT'X USA, INC. 1015 MAITLAND CENTER COMMONS SUITE 106A Maitland,  FL  32751
ContactJohn Sanders
CorrespondentJohn Sanders
SCIENT'X USA, INC. 1015 MAITLAND CENTER COMMONS SUITE 106A Maitland,  FL  32751
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-03
Decision Date2008-05-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.