OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Scorpio Posterior Cruciate Retaining Total Knee System.

Pre-market Notification Details

Device IDK974556
510k NumberK974556
Device Name:OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactDonna S Wilson
CorrespondentDonna S Wilson
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-05
Decision Date1998-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327044423 K974556 000
07613327028003 K974556 000
07613327027990 K974556 000
07613327027983 K974556 000
07613327027976 K974556 000
07613327027969 K974556 000
07613327027952 K974556 000
07613327027945 K974556 000
07613327027938 K974556 000
07613327027921 K974556 000
07613327027914 K974556 000
07613327027907 K974556 000
07613327027891 K974556 000
07613327027884 K974556 000
07613327027877 K974556 000
07613327027860 K974556 000
07613327028010 K974556 000
07613327028027 K974556 000
07613327044355 K974556 000
07613327028164 K974556 000
07613327028157 K974556 000
07613327028140 K974556 000
07613327028133 K974556 000
07613327028126 K974556 000
07613327028119 K974556 000
07613327028102 K974556 000
07613327028096 K974556 000
07613327028089 K974556 000
07613327028072 K974556 000
07613327028065 K974556 000
07613327028058 K974556 000
07613327028041 K974556 000
07613327028034 K974556 000
07613327027853 K974556 000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.