The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Scorpio Inset Patellar Component.
Device ID | K020830 |
510k Number | K020830 |
Device Name: | SCORPIO INSET PATELLAR COMPONENT |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Margaret F Crowe |
Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH 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 | 2002-03-14 |
Decision Date | 2002-06-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327014174 | K020830 | 000 |
07613327014129 | K020830 | 000 |
07613327014112 | K020830 | 000 |
07613327014082 | K020830 | 000 |