The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for First Step Unicompartmental Knee System.
| Device ID | K992287 |
| 510k Number | K992287 |
| Device Name: | FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-07 |
| Decision Date | 1999-11-16 |
| Summary: | summary |