MICRO/MINI N-PK(F) BONE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

ANULEX TECHNOLOGIES, INC

The following data is part of a premarket notification filed by Anulex Technologies, Inc with the FDA for Micro/mini N-pk(f) Bone Anchor.

Pre-market Notification Details

Device IDK121354
510k NumberK121354
Device Name:MICRO/MINI N-PK(F) BONE ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka,  MN  55343
ContactRachel Kennedy
CorrespondentRachel Kennedy
ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka,  MN  55343
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-04
Decision Date2012-11-09
Summary:summary

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