The following data is part of a premarket notification filed by Implantology Corp. with the FDA for Fpc/sfpc/rfpc Acetabular Component.
| Device ID | K915529 |
| 510k Number | K915529 |
| Device Name: | FPC/SFPC/RFPC ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| 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 | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-10 |
| Decision Date | 1993-07-13 |