The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Lps.
Device ID | K033959 |
510k Number | K033959 |
Device Name: | LPS |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Dina L Weissman |
Correspondent | Dina L Weissman DEPUY, INC. P.O. BOX 988 700 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 | 2003-12-22 |
Decision Date | 2004-07-01 |
Summary: | summary |