HEALIX ADVANCE PEEK ANCHOR

Screw, Fixation, Bone

Depuy Mitek

The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Healix Advance Peek Anchor.

Pre-market Notification Details

Device IDK120449
510k NumberK120449
Device Name:HEALIX ADVANCE PEEK ANCHOR
ClassificationScrew, Fixation, Bone
Applicant Depuy Mitek 325 Paramount Drive Raynham,  MA  02767
ContactYayoi Fujimaki
CorrespondentYayoi Fujimaki
Depuy Mitek 325 Paramount Drive Raynham,  MA  02767
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-14
Decision Date2012-05-11
Summary:summary

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