The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Sigma Ps Femoral Components.
| Device ID | K073529 |
| 510k Number | K073529 |
| Device Name: | DEPUY SIGMA PS FEMORAL COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Nancy Friddle |
| Correspondent | Nancy Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-17 |
| Decision Date | 2008-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295075523 | K073529 | 000 |
| 10603295075103 | K073529 | 000 |
| 10603295075073 | K073529 | 000 |
| 10603295075059 | K073529 | 000 |
| 10603295075042 | K073529 | 000 |
| 10603295075035 | K073529 | 000 |
| 10603295075028 | K073529 | 000 |
| 10603295075011 | K073529 | 000 |
| 10603295075530 | K073529 | 000 |
| 10603295075486 | K073529 | 000 |
| 10603295075462 | K073529 | 000 |
| 10603295075332 | K073529 | 000 |
| 10603295075295 | K073529 | 000 |
| 10603295075165 | K073529 | 000 |
| 10603295075080 | K073529 | 000 |
| 10603295075110 | K073529 | 000 |
| 10603295075127 | K073529 | 000 |
| 10603295075516 | K073529 | 000 |
| 10603295075509 | K073529 | 000 |
| 10603295075493 | K073529 | 000 |
| 10603295075479 | K073529 | 000 |
| 10603295075356 | K073529 | 000 |
| 10603295075349 | K073529 | 000 |
| 10603295075325 | K073529 | 000 |
| 10603295075318 | K073529 | 000 |
| 10603295075301 | K073529 | 000 |
| 10603295075288 | K073529 | 000 |
| 10603295075172 | K073529 | 000 |
| 10603295075158 | K073529 | 000 |
| 10603295075141 | K073529 | 000 |
| 10603295075134 | K073529 | 000 |
| 10603295075066 | K073529 | 000 |