ARC SURGICAL BIOTRAK SCREW

Screw, Fixation, Bone

ARC SURGICAL LLC.

The following data is part of a premarket notification filed by Arc Surgical Llc. with the FDA for Arc Surgical Biotrak Screw.

Pre-market Notification Details

Device IDK061763
510k NumberK061763
Device Name:ARC SURGICAL BIOTRAK SCREW
ClassificationScrew, Fixation, Bone
Applicant ARC SURGICAL LLC. 21300 NW JACOBSON RD. Hillsboro,  OR  97124
ContactEd Boehmer
CorrespondentEd Boehmer
ARC SURGICAL LLC. 21300 NW JACOBSON RD. Hillsboro,  OR  97124
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-22
Decision Date2006-09-19
Summary:summary

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