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 |