The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Sulzer Orthopedics Fluted Stems.
| Device ID | K982903 |
| 510k Number | K982903 |
| Device Name: | SULZER ORTHOPEDICS FLUTED STEMS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-18 |
| Decision Date | 1998-10-21 |
| Summary: | summary |