The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Lps Distal Femoral Component.
| Device ID | K063686 |
| 510k Number | K063686 |
| Device Name: | DEPUY LPS DISTAL FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Contact | Rebecca Lennard |
| Correspondent | Rebecca Lennard DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-12 |
| Decision Date | 2007-12-20 |
| Summary: | summary |