The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Sulzer Orthopedics Ms-30 Femoral Stem.
| Device ID | K001078 |
| 510k Number | K001078 |
| Device Name: | SULZER ORTHOPEDICS MS-30 FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-04 |
| Decision Date | 2000-06-23 |