TRIMED RADIAL BULLET

Plate, Fixation, Bone

TRI-MED, INC.

The following data is part of a premarket notification filed by Tri-med, Inc. with the FDA for Trimed Radial Bullet.

Pre-market Notification Details

Device IDK030877
510k NumberK030877
Device Name:TRIMED RADIAL BULLET
ClassificationPlate, Fixation, Bone
Applicant TRI-MED, INC. 159 KU'UKAMA ST. Kailua,,  HI  96734
ContactRobert J Medoff
CorrespondentRobert J Medoff
TRI-MED, INC. 159 KU'UKAMA ST. Kailua,,  HI  96734
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-20
Decision Date2004-02-05
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.