OSA RIGID INTERNAL FIXATION SYSTEM

Plate, Bone

OSTEOMED CORP.

The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osa Rigid Internal Fixation System.

Pre-market Notification Details

Device IDK021618
510k NumberK021618
Device Name:OSA RIGID INTERNAL FIXATION SYSTEM
ClassificationPlate, Bone
Applicant OSTEOMED CORP. 3750 REALTY RD. Addison,  TX  75001 -4311
ContactDawn T Holdeman
CorrespondentDawn T Holdeman
OSTEOMED CORP. 3750 REALTY RD. Addison,  TX  75001 -4311
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-16
Decision Date2002-08-08
Summary:summary

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