The following data is part of a premarket notification filed by Stelkast Company with the FDA for Stelkast Bipolar System.
| Device ID | K972961 |
| 510k Number | K972961 |
| Device Name: | STELKAST BIPOLAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | STELKAST COMPANY 800 VINIAL STREET, SUITE B-210 Pittsburg, PA 15212 |
| Contact | Donald A Stevens |
| Correspondent | Donald A Stevens STELKAST COMPANY 800 VINIAL STREET, SUITE B-210 Pittsburg, PA 15212 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1997-11-04 |