OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant

Pin, Fixation, Smooth

Ossio Ltd.

The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber™ Hammertoe Fixation System/ossiofiber™ Hammertoe Fixation Implant.

Pre-market Notification Details

Device IDK190652
510k NumberK190652
Device Name:OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
ClassificationPin, Fixation, Smooth
Applicant Ossio Ltd. 8 HaTochen St. Caesarea,  IL 3079861
ContactTaly Lindner
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-13
Decision Date2020-03-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290017630120 K190652 000
07290017630021 K190652 000
07290017630038 K190652 000
07290017630045 K190652 000
07290017630052 K190652 000
07290017630069 K190652 000
07290017630076 K190652 000
07290017630083 K190652 000
07290017630090 K190652 000
07290017630106 K190652 000
07290017630113 K190652 000
07290017630014 K190652 000

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