The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Pfc Sigma Knee Prosthesis.
| Device ID | K060515 |
| 510k Number | K060515 |
| Device Name: | DEPUY PFC SIGMA KNEE PROSTHESIS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295233947 | K060515 | 000 |
| 10603295233930 | K060515 | 000 |
| 10603295233923 | K060515 | 000 |
| 10603295233916 | K060515 | 000 |