The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Porocoat Porous Coating.
| Device ID | K931641 |
| 510k Number | K931641 |
| Device Name: | POROCOAT POROUS COATING |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Stephen Peoples |
| Correspondent | Stephen Peoples DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-02 |
| Decision Date | 1994-03-21 |