FDA 510(k) Applications Submitted by OSSIO Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K212594 08/16/2021 OSSIOfiber« Staple OSSIO Ltd.
K243760 12/06/2024 OSSIOfiber« Suture Anchor 2.5-3.5 mm Ossio Ltd.
K190652 03/13/2019 OSSIOfiberÖ Hammertoe Fixation System/OSSIOfiberÖ Hammertoe Fixation Implant Ossio Ltd.
K230750 03/17/2023 OSSIOfiber« Cannulated Trimmable Fixation Nail Ossio Ltd.
K221193 04/25/2022 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm OSSIO Ltd.
K251309 04/28/2025 OSSIOfiber« Suture Anchor OSSIO Ltd.
K181180 05/02/2018 OSSIOÖ Pin Product Family Ossio Ltd.
K231272 05/02/2023 OSSIOfiber« Pin Product Family, OSSIOfiber« Compression Screw, OSSIOfiber« Trimmable Fixation Nail OSSIO Ltd.
K241277 05/06/2024 OSSIOfiber« Threaded Trimmable Fixation Nail OSSIO Ltd.
K201803 06/30/2020 OSSIOfiberÖ Hammertoe Fixation System/OSSIOfiberÖ Hammertoe Fixation Implant Ossio Ltd.
K241932 07/01/2024 OSSIOfiber« Compression Staple OSSIO Ltd.
K233198 09/28/2023 OSSIOfiber« Threaded Trimmable Fixation Nails OSSIO Ltd.
K233302 09/29/2023 OSSIOfiber« Compression Staple Ossio Ltd.
K213415 10/19/2021 OSSIOfiber Suture Anchor OSSIO Ltd.
K213596 11/12/2021 OSSIOfiber Compression Screw, 3.5mm OSSIO Ltd.
K203465 11/24/2020 OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design OSSIO Ltd.
K193660 12/30/2019 OSSIOfiberÖ Compression Screws Ossio Ltd.


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