The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Stryker Compartmental Knee System.
| Device ID | K052917 |
| 510k Number | K052917 |
| Device Name: | STRYKER COMPARTMENTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | NPJ |
| Subsequent Product Code | HRY |
| Subsequent Product Code | HSX |
| Subsequent Product Code | KRR |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-17 |
| Decision Date | 2005-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327101140 | K052917 | 000 |
| 04546540318459 | K052917 | 000 |
| 04546540318466 | K052917 | 000 |
| 04546540318497 | K052917 | 000 |
| 04546540318527 | K052917 | 000 |
| 04546540318534 | K052917 | 000 |
| 07613327033861 | K052917 | 000 |
| 07613327033878 | K052917 | 000 |
| 07613327033885 | K052917 | 000 |
| 07613327033892 | K052917 | 000 |
| 07613327033908 | K052917 | 000 |
| 07613327033915 | K052917 | 000 |
| 07613327101072 | K052917 | 000 |
| 07613327101096 | K052917 | 000 |
| 07613327101119 | K052917 | 000 |
| 07613327101126 | K052917 | 000 |
| 07613327101133 | K052917 | 000 |
| 04546540318442 | K052917 | 000 |