The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex H-110 And H-120 Cemented Hip Stem System.
| Device ID | K925348 |
| 510k Number | K925348 |
| Device Name: | IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1993-05-12 |