ARTHROTEK INTERFERENCE SCREW

Screw, Fixation, Bone

BIOMET, INC.

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

Pre-market Notification Details

Device IDK982497
510k NumberK982497
Device Name:ARTHROTEK INTERFERENCE SCREW
ClassificationScrew, Fixation, Bone
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactMary Verstynen
CorrespondentMary Verstynen
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-20
Decision Date1998-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304009936 K982497 000
00880304008526 K982497 000
00880304007192 K982497 000
00880304006669 K982497 000
00880304004047 K982497 000
00880304004030 K982497 000
00880304003262 K982497 000

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