OSSIO , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254055OSSIOfiber® Suture AnchorFebruary 24, 2026
K252022OSSIOfiber® Interference ScrewAugust 19, 2025
K251309OSSIOfiber® Suture AnchorMay 27, 2025
K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmApril 3, 2025
K241932OSSIOfiber® Compression StapleAugust 28, 2024
K241277OSSIOfiber® Threaded Trimmable Fixation NailJuly 3, 2024
K233198OSSIOfiber® Threaded Trimmable Fixation NailsMarch 8, 2024
K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailDecember 1, 2023
K233302OSSIOfiber® Compression StapleNovember 16, 2023
K230750OSSIOfiber® Cannulated Trimmable Fixation NailSeptember 13, 2023
K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmDecember 23, 2022
K213415OSSIOfiber Suture AnchorMarch 28, 2022
K212594OSSIOfiber® StapleJanuary 21, 2022
K213596OSSIOfiber Compression Screw, 3.5mmDecember 21, 2021
K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber TrimmaJanuary 6, 2021
K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOctober 16, 2020
K193660OSSIOfiber™ Compression ScrewsJuly 30, 2020
K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantMarch 6, 2020
K181180OSSIO™ Pin Product FamilyJanuary 10, 2019