The following data is part of a premarket notification filed by Stelkast Company with the FDA for Proform Ha Hip System.
| Device ID | K934162 |
| 510k Number | K934162 |
| Device Name: | PROFORM HA HIP SYSTEM |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| 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 | JDO |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-27 |
| Decision Date | 1994-03-09 |