The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Modification: To Depuy Delta Ceramic Femoral Head.
| Device ID | K062748 |
| 510k Number | K062748 |
| Device Name: | MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-14 |
| Decision Date | 2006-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295033608 | K062748 | 000 |
| 10603295033592 | K062748 | 000 |