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 |