PROW FUSION-V

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-v.

Pre-market Notification Details

Device IDK153786
510k NumberK153786
Device Name:PROW FUSION-V
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NLT SPINE LTD 6 YAD HARUTZIM ST. Kfar-saba,  IL 4464103
ContactEti Zinger
CorrespondentJohn J Smith, M.d., J.d.
HOGAN LOVELLS US LLP 555 THRITEENTH STREET, NW Washington,  DC  20004
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-31
Decision Date2016-07-11
Summary:summary

NIH GUDID Devices

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