The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Fixion Hip System.
Device ID | K032730 |
510k Number | K032730 |
Device Name: | FIXION HIP SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia, IL 46728 |
Contact | Hila Wachsler-avrahami |
Correspondent | Hila Wachsler-avrahami DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia, IL 46728 |
Product Code | JDI |
Subsequent Product Code | JDG |
Subsequent Product Code | KWL |
Subsequent Product Code | LPH |
Subsequent Product Code | LWJ |
Subsequent Product Code | MBL |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-03 |
Decision Date | 2004-03-26 |
Summary: | summary |