Actis Medical Pty., Ltd.
Australia(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
SMART Osteotomy System Ref K260090
What Actis Medical Pty., Ltd. makes
Actis Medical designs and manufactures the SMART Osteotomy System, a surgical tool used for precise bone cutting and osteotomy procedures in orthopedic applications.
The company’s portfolio is regulated under FDA’s Class II device category and is listed via the 510(k) clearance pathway. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Actis Medical Pty., Ltd. manufacture?
Actis Medical Pty., Ltd. specializes in surgical tools, specifically designing and manufacturing the SMART Osteotomy System. This device is intended for precise bone cutting and osteotomy procedures within orthopedic surgery, helping surgeons perform controlled bone modifications.
Where is Actis Medical Pty., Ltd. based?
Actis Medical Pty., Ltd. is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs its device portfolio.
How are Actis Medical’s devices classified by regulatory authorities?
Actis Medical’s devices, including the SMART Osteotomy System, fall under the FDA’s Class II classification. This classification is assigned based on the device’s intended use and associated risks, requiring premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Actis Medical’s devices?
Actis Medical’s devices are listed in the FDA’s 510(k) clearance registry. This pathway is used to demonstrate that a new device is at least as safe and effective as an existing, legally marketed device, ensuring compliance with U.S. regulatory requirements.
Information
- Country
- Australia