The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Modification To Depuy Solution System Hip Prosthesis.
| Device ID | K030979 |
| 510k Number | K030979 |
| Device Name: | MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Karla A Ham |
| Correspondent | Karla A Ham DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE 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 | 2003-03-28 |
| Decision Date | 2003-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295061779 | K030979 | 000 |
| 10603295061397 | K030979 | 000 |
| 10603295061380 | K030979 | 000 |
| 10603295061373 | K030979 | 000 |
| 10603295061366 | K030979 | 000 |
| 10603295061359 | K030979 | 000 |
| 10603295061755 | K030979 | 000 |
| 10603295061748 | K030979 | 000 |
| 10603295061731 | K030979 | 000 |
| 10603295061724 | K030979 | 000 |
| 10603295061700 | K030979 | 000 |
| 10603295061694 | K030979 | 000 |
| 10603295061564 | K030979 | 000 |
| 10603295061557 | K030979 | 000 |
| 10603295061540 | K030979 | 000 |
| 10603295061533 | K030979 | 000 |
| 10603295061403 | K030979 | 000 |
| 10603295061441 | K030979 | 000 |
| 10603295061458 | K030979 | 000 |
| 10603295061762 | K030979 | 000 |
| 10603295061687 | K030979 | 000 |
| 10603295061670 | K030979 | 000 |
| 10603295061663 | K030979 | 000 |
| 10603295061656 | K030979 | 000 |
| 10603295061632 | K030979 | 000 |
| 10603295061625 | K030979 | 000 |
| 10603295061618 | K030979 | 000 |
| 10603295061601 | K030979 | 000 |
| 10603295061595 | K030979 | 000 |
| 10603295061588 | K030979 | 000 |
| 10603295061496 | K030979 | 000 |
| 10603295061489 | K030979 | 000 |
| 10603295061472 | K030979 | 000 |
| 10603295061465 | K030979 | 000 |
| 10603295061519 | K030979 | 000 |