MODIFICATION TO CENTAUR SPINAL SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modification To Centaur Spinal System.

Pre-market Notification Details

Device IDK001844
510k NumberK001844
Device Name:MODIFICATION TO CENTAUR SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
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 CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-19
Decision Date2000-07-19

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