The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Knee Prosthesis System Universal Stem Extensions And Femoral Metaphyseal Sleeves.
| Device ID | K063633 |
| 510k Number | K063633 |
| Device Name: | DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Steven J Wentworth |
| Correspondent | Steven J Wentworth DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 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 | 2006-12-06 |
| Decision Date | 2007-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295218036 | K063633 | 000 |
| 10603295217909 | K063633 | 000 |
| 10603295217893 | K063633 | 000 |
| 10603295217886 | K063633 | 000 |
| 10603295217879 | K063633 | 000 |
| 10603295217862 | K063633 | 000 |
| 10603295217855 | K063633 | 000 |
| 10603295217848 | K063633 | 000 |
| 10603295217831 | K063633 | 000 |
| 10603295217824 | K063633 | 000 |
| 10603295217817 | K063633 | 000 |
| 10603295217916 | K063633 | 000 |
| 10603295217923 | K063633 | 000 |
| 10603295218029 | K063633 | 000 |
| 10603295218012 | K063633 | 000 |
| 10603295218005 | K063633 | 000 |
| 10603295217992 | K063633 | 000 |
| 10603295217985 | K063633 | 000 |
| 10603295217978 | K063633 | 000 |
| 10603295217961 | K063633 | 000 |
| 10603295217954 | K063633 | 000 |
| 10603295217947 | K063633 | 000 |
| 10603295217930 | K063633 | 000 |
| 10603295217800 | K063633 | 000 |