The following data is part of a premarket notification filed by Implantology Corp. with the FDA for Ufc Hip Stem Component.
| Device ID | K924099 |
| 510k Number | K924099 |
| Device Name: | UFC HIP STEM COMPONENT |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | IMPLANTOLOGY CORP. 11 OAK LN. Pine Brook, NJ 07058 |
| Contact | Mark R Forte |
| Correspondent | Mark R Forte IMPLANTOLOGY CORP. 11 OAK LN. Pine Brook, NJ 07058 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1993-04-30 |