The following data is part of a premarket notification filed by Stelkast Company with the FDA for Proform Porous Beaded Femoral Stem.
| Device ID | K954466 |
| 510k Number | K954466 |
| Device Name: | PROFORM POROUS BEADED FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | STELKAST COMPANY 800 VINIAL ST. SUITE B-210 Pittsburgh, PA 15212 |
| Contact | Donald A Stevens |
| Correspondent | Donald A Stevens STELKAST COMPANY 800 VINIAL ST. SUITE B-210 Pittsburgh, PA 15212 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-25 |
| Decision Date | 1995-12-04 |