The following data is part of a premarket notification filed by Dj Orthopedics, Llc with the FDA for Total Knee Cemented, Semi-constrained.
| Device ID | K021740 |
| 510k Number | K021740 |
| Device Name: | TOTAL KNEE CEMENTED, SEMI-CONSTRAINED |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DJ ORTHOPEDICS, LLC 2985 SCOTT ST. Vista, CA 92083 |
| Contact | Nora C.r. York |
| Correspondent | Nora C.r. York DJ ORTHOPEDICS, LLC 2985 SCOTT ST. Vista, CA 92083 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-28 |
| Decision Date | 2002-09-23 |
| Summary: | summary |