The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Femoral Heads.
| Device ID | K011533 |
| 510k Number | K011533 |
| Device Name: | DEPUY 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 | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-18 |
| Decision Date | 2002-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295033295 | K011533 | 000 |
| 10603295033288 | K011533 | 000 |
| 10603295033271 | K011533 | 000 |
| 10603295033264 | K011533 | 000 |
| 10603295033257 | K011533 | 000 |
| 10603295033240 | K011533 | 000 |