The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Natural-knee Ii Patellofemoral Joint Prosthesis.
| Device ID | K002356 |
| 510k Number | K002356 |
| Device Name: | NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, 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 | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-02 |
| Decision Date | 2000-10-30 |