ORTHOPEDIC SCREW FIXATION

Screw, Fixation, Bone

OSTEOMED CORP.

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

Pre-market Notification Details

Device IDK932350
510k NumberK932350
Device Name:ORTHOPEDIC SCREW FIXATION
ClassificationScrew, 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 CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-14
Decision Date1995-07-05

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