TRIMED STERILE PRODUCT

Plate, Fixation, Bone

TRIMED, INC.

The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Sterile Product.

Pre-market Notification Details

Device IDK091156
510k NumberK091156
Device Name:TRIMED STERILE PRODUCT
ClassificationPlate, Fixation, Bone
Applicant TRIMED, INC. 28337 MAITLAND LANE Saugus,  CA  91350
ContactKelli Anderson
CorrespondentKelli Anderson
TRIMED, INC. 28337 MAITLAND LANE Saugus,  CA  91350
Product CodeHRS  
Subsequent Product CodeHTY
Subsequent Product CodeHWC
Subsequent Product CodeJDS
Subsequent Product CodeMBI
Subsequent Product CodeNDL
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-21
Decision Date2009-07-15
Summary:summary

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