XIA STAINLESS STEEL SYSTEM

Appliance, Fixation, Spinal Interlaminal

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Xia Stainless Steel System.

Pre-market Notification Details

Device IDK012870
510k NumberK012870
Device Name:XIA STAINLESS STEEL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactKaren Ariemma
CorrespondentKaren Ariemma
HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
Product CodeKWP  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-27
Decision Date2001-09-24
Summary:summary

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