The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Implex Hedrocel Modular Elliptical Acetabular Cup.
| Device ID | K001039 |
| 510k Number | K001039 |
| Device Name: | THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | John Schalago |
| Correspondent | John Schalago IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-31 |
| Decision Date | 2000-06-15 |