FDA.reportPublic FDA data

OSSIO LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30145540883014554088OSSIO LTD.1N2026-01-018 HaTochen St. Caesarea Central IL 3079861

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2265761723313961K254055OSSIOfiber® Suture AnchorMAI2026-02-24
2265761918169941K252022OSSIOfiber® Interference ScrewMAI2025-08-19
2265761601893207K251309OSSIOfiber® Suture AnchorMAI2025-05-27
2265761727635270K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI2025-04-03
2265761334450954K241932OSSIOfiber® Compression StapleMNU2024-08-28
2265761548382964K241277OSSIOfiber® Threaded Trimmable Fixation NailHWC2024-07-03
2265761273783507K233302OSSIOfiber® Compression StapleMNU2023-11-16
2265761329877209K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailHTY2023-12-01
2265761557795848K230750OSSIOfiber® Cannulated Trimmable Fixation NailHTY2023-09-13
2265761586547101K213596OSSIOfiber Compression Screw, 3.5mmHWC2021-12-21
2265761331436110K213415OSSIOfiber Suture AnchorMAI2022-03-28
2265761021031098K212594OSSIOfiber® StapleMNU2022-01-21
2265761800396120K193660OSSIOfiber™ Compression ScrewsHWC2020-07-30
2265761889334335K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantHTY2020-03-06
2265761968094236K181180OSSIO™ Pin Product FamilyHTY2019-01-10
2265761454462749
2265761463263679
2265761483529445
2265761504078623
2265761654565952
2265761726195989
2265761821488826
2265761880535993
2265762051887029

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAI52026-02-24
HTY42023-12-01
MNU32024-08-28
HWC32024-07-03

PMN#