ENCORE ANTERIOR SPINAL STAPLE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Encore Anterior Spinal Staple System.

Pre-market Notification Details

Device IDK030667
510k NumberK030667
Device Name:ENCORE ANTERIOR SPINAL STAPLE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
ContactDebbie De Los Santos
CorrespondentDebbie De Los Santos
ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-03
Decision Date2003-05-28
Summary:summary

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