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.
Device ID | K974556 |
510k Number | K974556 |
Device Name: | OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Contact | Donna S Wilson |
Correspondent | Donna S Wilson OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-05 |
Decision Date | 1998-02-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |