PROW FUSION-L

Intervertebral Fusion Device With Bone Graft, Lumbar

NLT SPINE LTD

The following data is part of a premarket notification filed by Nlt Spine Ltd with the FDA for Prow Fusion-l.

Pre-market Notification Details

Device IDK153665
510k NumberK153665
Device Name:PROW FUSION-L
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NLT SPINE LTD 6 YAD HARUTZIM ST. Kfar-saba,  IL 4464103
ContactEti Zinger
CorrespondentJohn J Smith
HOGAN LOVELLS US LLP 555 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-09-15
Summary:summary

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