ORTHOPEDIC WIRE

Staple, Fixation, Bone

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Orthopedic Wire.

Pre-market Notification Details

Device IDK031127
510k NumberK031127
Device Name:ORTHOPEDIC WIRE
ClassificationStaple, Fixation, Bone
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactDebra Bing
CorrespondentDebra Bing
HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-09
Decision Date2003-04-28
Summary:summary

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