The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Modular Cathcart Fracture System.
| Device ID | K903084 |
| 510k Number | K903084 |
| Device Name: | MODULAR CATHCART FRACTURE SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| 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 | LZY |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-12 |
| Decision Date | 1990-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295032892 | K903084 | 000 |
| 10603295032748 | K903084 | 000 |
| 10603295032755 | K903084 | 000 |
| 10603295032762 | K903084 | 000 |
| 10603295032779 | K903084 | 000 |
| 10603295032786 | K903084 | 000 |
| 10603295032793 | K903084 | 000 |
| 10603295032809 | K903084 | 000 |
| 10603295032816 | K903084 | 000 |
| 10603295032823 | K903084 | 000 |
| 10603295032830 | K903084 | 000 |
| 10603295032847 | K903084 | 000 |
| 10603295032854 | K903084 | 000 |
| 10603295032861 | K903084 | 000 |
| 10603295032878 | K903084 | 000 |
| 10603295032885 | K903084 | 000 |
| 10603295032731 | K903084 | 000 |