The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Sulzer Orthopedics Anatomical Shoulder Cemented Humeral Stem.
| Device ID | K003832 |
| 510k Number | K003832 |
| Device Name: | SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-11 |
| Decision Date | 2001-01-04 |