OSSIOfiber™ Compression Screws

Screw, Fixation, Bone

Ossio Ltd.

The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber™ Compression Screws.

Pre-market Notification Details

Device IDK193660
510k NumberK193660
Device Name:OSSIOfiber™ Compression Screws
ClassificationScrew, Fixation, Bone
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 CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-30
Decision Date2020-07-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290017630281 K193660 000
07290017630410 K193660 000
07290017630328 K193660 000
07290017630335 K193660 000
07290017630342 K193660 000
07290017630359 K193660 000
07290017630366 K193660 000
07290017630373 K193660 000
07290017630380 K193660 000
07290017630397 K193660 000
07290017630182 K193660 000
07290017630199 K193660 000
07290017630205 K193660 000
07290017630212 K193660 000
07290017630229 K193660 000
07290017630236 K193660 000
07290017630243 K193660 000
07290017630403 K193660 000

Trademark Results [OSSIOfiber]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSSIOFIBER
OSSIOFIBER
79255262 not registered Live/Pending
OSSIO LTD
2018-11-29

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