The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Fixion Unipolar Modular Hemi-hip System (fixion Mh).
| Device ID | K030972 |
| 510k Number | K030972 |
| Device Name: | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-28 |
| Decision Date | 2003-05-30 |
| Summary: | summary |