ORTHOPEDIC BONE PLATE

Plate, Fixation, Bone

OSTEOMED CORP.

The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Orthopedic Bone Plate.

Pre-market Notification Details

Device IDK932352
510k NumberK932352
Device Name:ORTHOPEDIC BONE PLATE
ClassificationPlate, Fixation, Bone
Applicant OSTEOMED CORP. 2753 FREEMAN ST. Fort Wayne,  IN  46802
ContactBilly Darmawan
CorrespondentBilly Darmawan
OSTEOMED CORP. 2753 FREEMAN ST. Fort Wayne,  IN  46802
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-14
Decision Date1995-07-05

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