The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Articul/eze Femoral Heads.
| Device ID | K980513 |
| 510k Number | K980513 |
| Device Name: | ARTICUL/EZE FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Cheryl K Hastings |
| Correspondent | Cheryl K Hastings DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-10 |
| Decision Date | 1998-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295033974 | K980513 | 000 |
| 10603295033950 | K980513 | 000 |
| 10603295033936 | K980513 | 000 |
| 10603295033912 | K980513 | 000 |
| 10603295033899 | K980513 | 000 |
| 10603295033356 | K980513 | 000 |
| 10603295033349 | K980513 | 000 |