GAIA Lumbar Interbody Fusion Device (LIFD) Family

Intervertebral Fusion Device With Bone Graft, Lumbar

PrinterPrezz

The following data is part of a premarket notification filed by Printerprezz with the FDA for Gaia Lumbar Interbody Fusion Device (lifd) Family.

Pre-market Notification Details

Device IDK201939
510k NumberK201939
Device Name:GAIA Lumbar Interbody Fusion Device (LIFD) Family
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant PrinterPrezz 4110 Clipper CT Fremont,  CA  94538
ContactKishore Karkera
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-13
Decision Date2020-10-08

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