AVS ASL PEEK SPACER SYSTEM

Spinal Vertebral Body Replacement Device

STRYKER SPINE

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Avs Asl Peek Spacer System.

Pre-market Notification Details

Device IDK061836
510k NumberK061836
Device Name:AVS ASL PEEK SPACER SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactSimona Voic
CorrespondentSimona Voic
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-29
Decision Date2006-08-03
Summary:summary

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