Precision Spine Interspinous Plate System

Spinous Process Plate

PRECISION SPINE, INC.

The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Precision Spine Interspinous Plate System.

Pre-market Notification Details

Device IDK151863
510k NumberK151863
Device Name:Precision Spine Interspinous Plate System
ClassificationSpinous Process Plate
Applicant PRECISION SPINE, INC. 5 SYLVAN WAY, SUITE 220 Parsippany,  NJ  07930
ContactMichael C. Dawson
CorrespondentKenneth C. Maxwell
EMPIRICAL TESTING CORP. 4628 NORTHPARK DRIVE Colorado Springs,  CO  80918
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-08
Decision Date2015-08-07
Summary:summary

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