The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Scorpio Total Knee System.
| Device ID | K033972 |
| 510k Number | K033972 |
| Device Name: | SCORPIO TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327033472 | K033972 | 000 |
| 07613327033465 | K033972 | 000 |
| 07613327033458 | K033972 | 000 |
| 07613327033441 | K033972 | 000 |
| 07613327033434 | K033972 | 000 |
| 07613327033427 | K033972 | 000 |
| 07613327033410 | K033972 | 000 |
| 07613327033403 | K033972 | 000 |