The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Stryker Compartmental Knee System Line Extension.
| Device ID | K082567 |
| 510k Number | K082567 |
| Device Name: | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HRY |
| Subsequent Product Code | HSX |
| Subsequent Product Code | KRR |
| Subsequent Product Code | NPJ |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-04 |
| Decision Date | 2008-10-03 |
| Summary: | summary |