SPINOUS PROCESS FUSION (SPF) PLATE

Spinous Process Plate

SPINAL SIMPLICITY, LLC

The following data is part of a premarket notification filed by Spinal Simplicity, Llc with the FDA for Spinous Process Fusion (spf) Plate.

Pre-market Notification Details

Device IDK140046
510k NumberK140046
Device Name:SPINOUS PROCESS FUSION (SPF) PLATE
ClassificationSpinous Process Plate
Applicant SPINAL SIMPLICITY, LLC 1835 MARKET ST. 29TH FLOOR Philadelphia,  PA  19103
ContactJanice M Hogan
CorrespondentJanice M Hogan
SPINAL SIMPLICITY, LLC 1835 MARKET ST. 29TH FLOOR Philadelphia,  PA  19103
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-08
Decision Date2015-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M9431000040160 K140046 000
M9431000040140 K140046 000
M9431000040120 K140046 000
M9431000040100 K140046 000
M9431000040080 K140046 000

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