The following data is part of a premarket notification filed by Implex Corp. with the FDA for H-220 Press-fit Acetabular Cup System.
| Device ID | K926134 |
| 510k Number | K926134 |
| Device Name: | H-220 PRESS-FIT ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | James E Malayter |
| Correspondent | James E Malayter IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-07 |
| Decision Date | 1993-10-15 |