The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Scorpio Low Profile Tibial Tray.
| Device ID | K032829 |
| 510k Number | K032829 |
| Device Name: | SCORPIO LOW PROFILE TIBIAL TRAY |
| 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 | 2003-09-11 |
| Decision Date | 2003-12-10 |
| Summary: | summary |