OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

Pin, Fixation, Smooth

OSSIO Ltd.

The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber Cannulated Trimmable Fixation Nail, Ossiofiber Trimmable Fixation Nail, Ossiofiber Trimmable Fixation Nail, Cannulated Design.

Pre-market Notification Details

Device IDK203465
510k NumberK203465
Device Name:OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
ClassificationPin, Fixation, Smooth
Applicant OSSIO Ltd. 8 HaTochen St. Caesarea,  IL 3079861
ContactTaly Lindner
CorrespondentDavid Mcgurl
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-24
Decision Date2021-01-06

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