POWER TEK II

Arthroscope

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Power Tek Ii.

Pre-market Notification Details

Device IDK020761
510k NumberK020761
Device Name:POWER TEK II
ClassificationArthroscope
Applicant BIOMET, INC. 56 EAST BELL DR. Warsaw,  IN  46581 -0587
ContactPatricia S Beres
CorrespondentPatricia S Beres
BIOMET, INC. 56 EAST BELL DR. Warsaw,  IN  46581 -0587
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-07
Decision Date2002-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304460492 K020761 000
00880304460478 K020761 000
00880304454538 K020761 000

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