XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY

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 Spine System Sacral Block Assembly.

Pre-market Notification Details

Device IDK001653
510k NumberK001653
Device Name:XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactMary-catherine Dillon
CorrespondentMary-catherine Dillon
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-30
Decision Date2000-08-18

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