The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Sigma Xlk Tibial Inserts.
| Device ID | K040166 |
| 510k Number | K040166 |
| Device Name: | DEPUY SIGMA XLK TIBIAL INSERTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Cheryl K Hastings |
| Correspondent | Cheryl K Hastings DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-26 |
| Decision Date | 2004-02-23 |
| Summary: | summary |