DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, Wedge.

Pre-market Notification Details

Device IDK122015
510k NumberK122015
Device Name:DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR Mahwah,  NJ  07430
ContactChristie Pencinger
CorrespondentChristie Pencinger
HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR Mahwah,  NJ  07430
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-10
Decision Date2013-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327142631 K122015 000
07613327033755 K122015 000
07613327033762 K122015 000
07613327033786 K122015 000
07613327048216 K122015 000
07613327048933 K122015 000
07613327049930 K122015 000
07613327142525 K122015 000
07613327142532 K122015 000
07613327142549 K122015 000
07613327142556 K122015 000
07613327142563 K122015 000
07613327142570 K122015 000
07613327142587 K122015 000
07613327142594 K122015 000
07613327142600 K122015 000
07613327142617 K122015 000
07613327142624 K122015 000
04546540276520 K122015 000

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