BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.

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.

Pre-market Notification Details

Device IDK011390
510k NumberK011390
Device Name:BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia,  IL 46728
ContactElad Magal
CorrespondentElad Magal
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia,  IL 46728
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-07
Decision Date2001-06-06

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