The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Lsf Ha Coated Femoral Hip.
| Device ID | K915617 |
| 510k Number | K915617 |
| Device Name: | LSF HA COATED FEMORAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Contact | Howard Mann |
| Correspondent | Howard Mann IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-16 |
| Decision Date | 1992-05-28 |