The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Solar Shoulder Humeral Bearing Head.
| Device ID | K990598 |
| 510k Number | K990598 |
| Device Name: | OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Marybeth Naughton |
| Correspondent | Marybeth Naughton HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-24 |
| Decision Date | 1999-03-15 |
| Summary: | summary |