Data / Medical devices / Israel / Arcuro Medical Ltd.
Arcuro Medical Ltd.: FDA-registered device maker in Misgav Northern, Israel, 3 510(k) clearances
Arcuro Medical Ltd. is registered with the FDA (registration 3016926753) in Misgav Northern, Israel. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016926753
- Address
- 17 Tchelet St., Misgav Business Park, Misgav Northern, Israel, 2017400
- Owner or operator
- Arcuro Medical Ltd. (10074120)
- Roles
- Manufacturer
- First device listed
- May 19, 2020
- Registered through
- 2026
- Brand names listed
- SuperBall, SuperBall Meniscal Repair System, SuperBall Meniscal Repair System, 12 Reverse, SuperBall Meniscal Repair System, 24 Up, SuperBall-RC 12 degree inserter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | 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 19, 2025 | K244015 | SuperBall-RC | MBI | Substantially Equivalent | Arcuro Medical , Ltd. | accessdata.fda.gov |
| August 10, 2023 | K223500 | SuperBall Meniscal Repair System | GAT | Substantially Equivalent | Arcuro Medical , Ltd. | accessdata.fda.gov |
| June 5, 2018 | K180191 | SuperBall Meniscal Repair System | GAT | Substantially Equivalent | Arcuro Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
Updated February 19, 2025. 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.