The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for New Jersey Modular Femoral Hip.
| Device ID | K853655 |
| 510k Number | K853655 |
| Device Name: | NEW JERSEY MODULAR FEMORAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Stephen M Doyle |
| Correspondent | Stephen M Doyle 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 | 1985-09-03 |
| Decision Date | 1985-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295001270 | K853655 | 000 |
| 10603295001263 | K853655 | 000 |
| 10603295001256 | K853655 | 000 |