Cannulated Fasteners And Nuts

Screw, Fixation, Bone

OsteoCentric Technologies

The following data is part of a premarket notification filed by Osteocentric Technologies with the FDA for Cannulated Fasteners And Nuts.

Pre-market Notification Details

Device IDK210754
510k NumberK210754
Device Name:Cannulated Fasteners And Nuts
ClassificationScrew, Fixation, Bone
Applicant OsteoCentric Technologies 75 West 300 North, Suite #150 Logan,  UT  84321
ContactTodd Evans
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-04-14

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