The following data is part of a premarket notification filed by Disco-o-tech Medical Technologies, Ltd. with the FDA for Fixion Dynamic Hip Screw System (fixion Dhs).
| Device ID | K031401 |
| 510k Number | K031401 |
| Device Name: | FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNOAT ST. Herzlia, IL 46728 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNOAT ST. Herzlia, IL 46728 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-05 |
| Decision Date | 2003-08-06 |
| Summary: | summary |