The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Replacement Acetabular Cup Insert.
| Device ID | K964882 |
| 510k Number | K964882 |
| Device Name: | IMPLEX REPLACEMENT ACETABULAR CUP INSERT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-05 |
| Decision Date | 1997-03-13 |