PLS (POSTERIOR LUMBAR SYSTEM)

Orthosis, Spondylolisthesis Spinal Fixation

SINTEA PLUSTEK, LLC

The following data is part of a premarket notification filed by Sintea Plustek, Llc with the FDA for Pls (posterior Lumbar System).

Pre-market Notification Details

Device IDK140787
510k NumberK140787
Device Name:PLS (POSTERIOR LUMBAR SYSTEM)
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SINTEA PLUSTEK, LLC 11821 BRAMBLE COVE DRIVE Ft. Myers,  FL  33905
ContactRich Jansen
CorrespondentRich Jansen
SINTEA PLUSTEK, LLC 11821 BRAMBLE COVE DRIVE Ft. Myers,  FL  33905
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-31
Decision Date2014-05-30

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