The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Ceramic Femoral Heads.
| Device ID | K031803 |
| 510k Number | K031803 |
| Device Name: | DEPUY CERAMIC FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-11 |
| Decision Date | 2003-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295033639 | K031803 | 000 |
| 10603295033417 | K031803 | 000 |
| 10603295033424 | K031803 | 000 |
| 10603295033431 | K031803 | 000 |
| 10603295033448 | K031803 | 000 |
| 10603295033455 | K031803 | 000 |
| 10603295033561 | K031803 | 000 |
| 10603295033578 | K031803 | 000 |
| 10603295033585 | K031803 | 000 |
| 10603295033615 | K031803 | 000 |
| 10603295033622 | K031803 | 000 |
| 10603295033400 | K031803 | 000 |