The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Bonus-orthopedic Bone Screw Fixation System.
| Device ID | K011390 |
| 510k Number | K011390 |
| Device Name: | BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia, IL 46728 |
| Contact | Elad Magal |
| Correspondent | Elad Magal DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia, IL 46728 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-06-06 |