The following data is part of a premarket notification filed by Implantology Corp. with the FDA for Bhr Bipolar Femoral Head Component.
| Device ID | K915528 |
| 510k Number | K915528 |
| Device Name: | BHR BIPOLAR FEMORAL HEAD COMPONENT |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| 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 | LZY |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-10 |
| Decision Date | 1993-06-29 |