The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Lsf(tm) Total Hip System.
| Device ID | K901460 |
| 510k Number | K901460 |
| Device Name: | LSF(TM) TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Contact | Laine Mashburn |
| Correspondent | Laine Mashburn IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-28 |
| Decision Date | 1990-05-22 |