ACUMED SMALL BONE LOCKING ROD SYSTEM II

Rod, Fixation, Intramedullary And Accessories

ACUMED LLC

The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Small Bone Locking Rod System Ii.

Pre-market Notification Details

Device IDK031438
510k NumberK031438
Device Name:ACUMED SMALL BONE LOCKING ROD SYSTEM II
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro,  OR  97124 -9432
ContactEd Boehmer
CorrespondentEd Boehmer
ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro,  OR  97124 -9432
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-06
Decision Date2003-07-17
Summary:summary

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