The following data is part of a premarket notification filed by Stelkast Company with the FDA for Proclass Press Fit Hip Stem.
| Device ID | K032110 |
| 510k Number | K032110 |
| Device Name: | PROCLASS PRESS FIT HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | STELKAST COMPANY 200 HIDDEN VALLEY RD. Mcmurray, PA 15317 |
| Contact | Donald A Stevens |
| Correspondent | Donald A Stevens STELKAST COMPANY 200 HIDDEN VALLEY RD. Mcmurray, PA 15317 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-09 |
| Decision Date | 2003-09-22 |