Born PT-LIF Cage HA

Intervertebral Fusion Device With Bone Graft, Lumbar

SpineworxX AG

The following data is part of a premarket notification filed by Spineworxx Ag with the FDA for Born Pt-lif Cage Ha.

Pre-market Notification Details

Device IDK202380
510k NumberK202380
Device Name:Born PT-LIF Cage HA
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SpineworxX AG Schuppisstrasse 10 St. Gallen,  CH 9016
ContactAouda Ouzzaa
CorrespondentCassandra Petrov
JALEX Medical 27865 Clemens Rd Suite 3 Westlake,  OH  44145
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-20
Decision Date2021-02-19

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