ESCALATE LAMINOPLASTY SYSTEM

Orthosis, Spine, Plate, Laminoplasty, Metal

STRYKER SPINE

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Escalate Laminoplasty System.

Pre-market Notification Details

Device IDK113802
510k NumberK113802
Device Name:ESCALATE LAMINOPLASTY SYSTEM
ClassificationOrthosis, Spine, Plate, Laminoplasty, Metal
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07430
ContactSimona Voic
CorrespondentSimona Voic
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07430
Product CodeNQW  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-23
Decision Date2012-04-16
Summary:summary

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