The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Scorpio Knee System - Tibial Inserts.
| Device ID | K033342 |
| 510k Number | K033342 |
| Device Name: | SCORPIO KNEE SYSTEM - TIBIAL INSERTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene 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 | 2003-10-17 |
| Decision Date | 2004-01-15 |
| Summary: | summary |