The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Lsf (r) Total Hip System - Bipolar Component.
| Device ID | K883212 |
| 510k Number | K883212 |
| Device Name: | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Contact | Peter J Scranton |
| Correspondent | Peter J Scranton IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-29 |
| Decision Date | 1988-11-22 |