The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Implex Hedrocel Acetabular Augment, Xx-yyy-zzzz.
| Device ID | K001471 |
| 510k Number | K001471 |
| Device Name: | THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | John A Schalago |
| Correspondent | John A Schalago IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-11 |
| Decision Date | 2000-08-07 |