The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Natural-knee Ii System Cocr Tibial Baseplate.
| Device ID | K021578 |
| 510k Number | K021578 |
| Device Name: | NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-14 |
| Decision Date | 2002-08-09 |
| Summary: | summary |