The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Lsf Diagnostic Related Group Cemented Hip.
| Device ID | K913616 |
| 510k Number | K913616 |
| Device Name: | LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Contact | James Abraham |
| Correspondent | James Abraham IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-13 |
| Decision Date | 1991-11-07 |