Data / Medical devices / Israel / Ossio Ltd.
Ossio Ltd.: FDA-registered device maker in Caesarea Central, Israel, 15 510(k) clearances
Ossio Ltd. is registered with the FDA (registration 3014554088) in Caesarea Central, Israel. It lists 13 device types. The FDA files 15 510(k) clearances under its listings, the newest dated February 24, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014554088
- Address
- 8 HaTochen St., Caesarea Central, Israel, 3079861
- Owner or operator
- Ossio Ltd. (10059524)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- January 30, 2019
- Registered through
- 2027
- Brand names listed
- 1.8mm Instrument Pack For 2.5mm Suture Anchor, Compression Screw Instruments, Hammertoe Instrumentation Kit, Size Medium, OSSIO Compression Screw Instruments, OSSIO Drill Bit, OSSIO Drill Bit & Drill Guide, OSSIO Drill Bit & Drill Guide Pack, OSSIO Drill Guide and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Drill, Ligament | LXI | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Staple Driver | HXJ | 1 | Manufacturer | accessdata.fda.gov |
| Staple, Absorbable | MNU | 2 | Manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2026 | K254055 | OSSIOfiber® Suture Anchor | MAI | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| August 19, 2025 | K252022 | OSSIOfiber® Interference Screw | MAI | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| May 27, 2025 | K251309 | OSSIOfiber® Suture Anchor | MAI | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| April 3, 2025 | K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | MAI | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| August 28, 2024 | K241932 | OSSIOfiber® Compression Staple | MNU | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| July 3, 2024 | K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | HWC | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| December 1, 2023 | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | HTY | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| November 16, 2023 | K233302 | OSSIOfiber® Compression Staple | MNU | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| September 13, 2023 | K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | HTY | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| March 28, 2022 | K213415 | OSSIOfiber Suture Anchor | MAI | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| January 21, 2022 | K212594 | OSSIOfiber® Staple | MNU | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| December 21, 2021 | K213596 | OSSIOfiber Compression Screw, 3.5mm | HWC | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| July 30, 2020 | K193660 | OSSIOfiber Compression Screws | HWC | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| March 6, 2020 | K190652 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant | HTY | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
| January 10, 2019 | K181180 | OSSIO Pin Product Family | HTY | Substantially Equivalent | OSSIO , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Punch, Surgical
- All makers of Pin, Fixation, Smooth
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Template
- All makers of Orthopedic Tray
- All makers of Screw, Fixation, Bone
Updated February 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.