The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Sulzer Orthopedics Allegretto Unicompartmental Knee.
| Device ID | K011954 |
| 510k Number | K011954 |
| Device Name: | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Bruce Waldon |
| Correspondent | Bruce Waldon SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-22 |
| Decision Date | 2001-09-19 |
| Summary: | summary |