The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Apex Hole Eliminator Ps.
| Device ID | K963309 |
| 510k Number | K963309 |
| Device Name: | APEX HOLE ELIMINATOR PS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. 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 | 1996-08-22 |
| Decision Date | 1996-11-12 |
| Summary: | summary |