The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy C-stem System.
| Device ID | K982918 |
| 510k Number | K982918 |
| Device Name: | DEPUY C-STEM SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Sally Foust |
| Correspondent | Sally Foust DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| Subsequent Product Code | LZN |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-19 |
| Decision Date | 1998-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295236801 | K982918 | 000 |
| 10603295235231 | K982918 | 000 |
| 10603295235224 | K982918 | 000 |
| 10603295235217 | K982918 | 000 |
| 10603295235200 | K982918 | 000 |
| 10603295235194 | K982918 | 000 |
| 10603295235187 | K982918 | 000 |
| 10603295235170 | K982918 | 000 |
| 10603295236351 | K982918 | 000 |
| 10603295235248 | K982918 | 000 |
| 10603295235255 | K982918 | 000 |
| 10603295236795 | K982918 | 000 |
| 10603295236788 | K982918 | 000 |
| 10603295236771 | K982918 | 000 |
| 10603295236764 | K982918 | 000 |
| 10603295236757 | K982918 | 000 |
| 10603295235286 | K982918 | 000 |
| 10603295235279 | K982918 | 000 |
| 10603295235262 | K982918 | 000 |
| 10603295235958 | K982918 | 000 |