ARTHREX BIOABSORBABLE INTERFERENCE SCREW

Screw, Fixation, Bone

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bioabsorbable Interference Screw.

Pre-market Notification Details

Device IDK945303
510k NumberK945303
Device Name:ARTHREX BIOABSORBABLE INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples,  FL  33942
ContactKen Durbin
CorrespondentKen Durbin
ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples,  FL  33942
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-28
Decision Date1996-01-25

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