OSSIO™ Pin Product Family

Pin, Fixation, Smooth

Ossio Ltd.

The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossio™ Pin Product Family.

Pre-market Notification Details

Device IDK181180
510k NumberK181180
Device Name:OSSIO™ Pin Product Family
ClassificationPin, Fixation, Smooth
Applicant Ossio Ltd. 8 HaTochen St. Caesarea,  IL 3088900
ContactTaly Lindner
CorrespondentJanice M. Hogan
Hogan Lovells US LLP 1735 Market Street Floor 23 Philadelphia,  PA  19103
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-02
Decision Date2019-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290017630007 K181180 000

Trademark Results [OSSIO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSSIO
OSSIO
88021850 5921948 Live/Registered
Ossio LTD
2018-06-30

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