OGDEN ANCHOR

Screw, Fixation, Bone

AMERICAN MEDICAL ELECTRONICS, INC.

The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Ogden Anchor.

Pre-market Notification Details

Device IDK950875
510k NumberK950875
Device Name:OGDEN ANCHOR
ClassificationScrew, Fixation, Bone
Applicant AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson,  TX  75081
ContactMary Biggers
CorrespondentMary Biggers
AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson,  TX  75081
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-28
Decision Date1995-07-11

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