REFLEX HYBRID ACP SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

STRYKER SPINE

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Reflex Hybrid Acp System.

Pre-market Notification Details

Device IDK062310
510k NumberK062310
Device Name:REFLEX HYBRID ACP SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactSimona Voic
CorrespondentSimona Voic
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-08
Decision Date2006-08-18
Summary:summary

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