The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Solution System Hip Prosthesis.
| Device ID | K060581 |
| 510k Number | K060581 |
| Device Name: | DEPUY SOLUTION SYSTEM HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Anne M Schuler |
| Correspondent | Anne M Schuler DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-07 |
| Decision Date | 2006-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295061717 | K060581 | 000 |
| 10603295061335 | K060581 | 000 |
| 10603295061342 | K060581 | 000 |
| 10603295061410 | K060581 | 000 |
| 10603295061427 | K060581 | 000 |
| 10603295061434 | K060581 | 000 |
| 10603295061502 | K060581 | 000 |
| 10603295061571 | K060581 | 000 |
| 10603295061649 | K060581 | 000 |
| 10603295061328 | K060581 | 000 |