The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Lsf* Total Hip System.
Device ID | K855017 |
510k Number | K855017 |
Device Name: | LSF* 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 | 1985-12-16 |
Decision Date | 1986-06-11 |