The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Lsf Total Hip System - Muller-type Acetabular Cup.
Device ID | K920021 |
510k Number | K920021 |
Device Name: | LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
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 | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-02 |
Decision Date | 1992-03-25 |