The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Modified Depuy Acetabular Cup System* Hip Aceta..
| Device ID | K900832 |
| 510k Number | K900832 |
| Device Name: | MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA. |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Kenneth G Roberts |
| Correspondent | Kenneth G Roberts DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-22 |
| Decision Date | 1990-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295019633 | K900832 | 000 |
| 10603295019411 | K900832 | 000 |
| 10603295019428 | K900832 | 000 |
| 10603295019435 | K900832 | 000 |
| 10603295019442 | K900832 | 000 |
| 10603295019589 | K900832 | 000 |
| 10603295019596 | K900832 | 000 |
| 10603295019602 | K900832 | 000 |
| 10603295019619 | K900832 | 000 |
| 10603295019626 | K900832 | 000 |
| 10603295019404 | K900832 | 000 |