Company · IL
OSSIO , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2026 | K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail OSSIO , Ltd., IL | HWC |
| Feb 24, 2026 | K254055 | OSSIOfiber® Suture Anchor OSSIO , Ltd., IL | MAI |
| Aug 19, 2025 | K252022 | OSSIOfiber® Interference Screw OSSIO , Ltd., IL | MAI |
| May 27, 2025 | K251309 | OSSIOfiber® Suture Anchor OSSIO , Ltd., IL | MAI |
| Apr 3, 2025 | K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm OSSIO , Ltd., IL | MAI |
| Aug 28, 2024 | K241932 | OSSIOfiber® Compression Staple OSSIO , Ltd., IL | MNU |
| Jul 3, 2024 | K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail OSSIO , Ltd., IL | HWC |
| Mar 8, 2024 | K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails OSSIO , Ltd., IL | HWC |
| Dec 1, 2023 | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail OSSIO , Ltd., IL | HTY |
| Nov 16, 2023 | K233302 | OSSIOfiber® Compression Staple OSSIO , Ltd., IL | MNU |
| Sep 13, 2023 | K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail OSSIO , Ltd., IL | HTY |
| Dec 23, 2022 | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm OSSIO , Ltd., IL | HWC |
| Mar 28, 2022 | K213415 | OSSIOfiber Suture Anchor OSSIO , Ltd., IL | MAI |
| Jan 21, 2022 | K212594 | OSSIOfiber® Staple OSSIO , Ltd., IL | MNU |
| Dec 21, 2021 | K213596 | OSSIOfiber Compression Screw, 3.5mm OSSIO , Ltd., IL | HWC |
| Jan 6, 2021 | K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, C OSSIO , Ltd., IL | HTY |
| Oct 16, 2020 | K201803 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant OSSIO , Ltd., IL | HTY |
| Jul 30, 2020 | K193660 | OSSIOfiber Compression Screws OSSIO , Ltd., IL | HWC |
| Mar 6, 2020 | K190652 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant OSSIO , Ltd., IL | HTY |
| Jan 10, 2019 | K181180 | OSSIO Pin Product Family OSSIO , Ltd., IL | HTY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||