The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Hps Ii Smooth Stem.
| Device ID | K860701 |
| 510k Number | K860701 |
| Device Name: | HPS II SMOOTH STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Nancy Sincroft |
| Correspondent | Nancy Sincroft DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-25 |
| Decision Date | 1986-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295001423 | K860701 | 000 |
| 10603295001416 | K860701 | 000 |
| 10603295001355 | K860701 | 000 |
| 10603295001348 | K860701 | 000 |
| 10603295001331 | K860701 | 000 |
| 10603295001324 | K860701 | 000 |
| 10603295001294 | K860701 | 000 |
| 10603295001287 | K860701 | 000 |