OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS

Orthosis, Spinal Pedicle Fixation

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Spinal System-expanded Indications.

Pre-market Notification Details

Device IDK990059
510k NumberK990059
Device Name:OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactKate Sutton
CorrespondentKate Sutton
HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-08
Decision Date1999-01-28
Summary:summary

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