NORMED TITANIUM OSTEOTOMY PLATING SYSTEM

Plate, Fixation, Bone

OSTEOMEDICS, INC.

The following data is part of a premarket notification filed by Osteomedics, Inc. with the FDA for Normed Titanium Osteotomy Plating System.

Pre-market Notification Details

Device IDK022325
510k NumberK022325
Device Name:NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
ClassificationPlate, Fixation, Bone
Applicant OSTEOMEDICS, INC. 809 CARTER LN. Paramus,  NJ  07652
ContactAlbert Enayati
CorrespondentAlbert Enayati
OSTEOMEDICS, INC. 809 CARTER LN. Paramus,  NJ  07652
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-17
Decision Date2002-09-09
Summary:summary

NIH GUDID Devices

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