The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Scorpio Total Knee System - Posterior Stabilized Tibial Inserts.
| Device ID | K040964 |
| 510k Number | K040964 |
| Device Name: | SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-14 |
| Decision Date | 2004-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327102222 | K040964 | 000 |
| 07613154005796 | K040964 | 000 |
| 07613153992554 | K040964 | 000 |
| 07613153992523 | K040964 | 000 |
| 07613153992516 | K040964 | 000 |
| 07613153992509 | K040964 | 000 |
| 07613153992493 | K040964 | 000 |
| 07613153992486 | K040964 | 000 |
| 07613153992479 | K040964 | 000 |
| 07613153992462 | K040964 | 000 |
| 07613153992455 | K040964 | 000 |
| 07613153992448 | K040964 | 000 |
| 07613153992431 | K040964 | 000 |
| 07613153992424 | K040964 | 000 |
| 07613154005871 | K040964 | 000 |
| 07613327102024 | K040964 | 000 |
| 07613327102062 | K040964 | 000 |
| 07613327102215 | K040964 | 000 |
| 07613327102208 | K040964 | 000 |
| 07613327102192 | K040964 | 000 |
| 07613327102185 | K040964 | 000 |
| 07613327102178 | K040964 | 000 |
| 07613327102161 | K040964 | 000 |
| 07613327102154 | K040964 | 000 |
| 07613327102147 | K040964 | 000 |
| 07613327102123 | K040964 | 000 |
| 07613327102116 | K040964 | 000 |
| 07613327102093 | K040964 | 000 |
| 07613327102086 | K040964 | 000 |
| 07613327102079 | K040964 | 000 |
| 07613153992417 | K040964 | 000 |