The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Hep Acetabular Revision Cup, Cemented Or Cementless Model A-240 System.
| Device ID | K980486 |
| 510k Number | K980486 |
| Device Name: | IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Robert Poggie |
| Correspondent | Robert Poggie IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-09 |
| Decision Date | 1998-04-14 |
| Summary: | summary |