The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Solar Shoulder Bipolar System.
| Device ID | K990712 |
| 510k Number | K990712 |
| Device Name: | OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM |
| Classification | Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented |
| 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 | MJT |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-04 |
| Decision Date | 1999-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327137897 | K990712 | 000 |
| 07613327137774 | K990712 | 000 |
| 07613327137767 | K990712 | 000 |
| 07613327137729 | K990712 | 000 |
| 07613327137712 | K990712 | 000 |
| 07613327137699 | K990712 | 000 |
| 07613327137682 | K990712 | 000 |