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 |