Bonalive Biomaterials, Ltd.
FI Last updated 22 Oct 2026
- Devices
- 2
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
BonAlive Granules Ref K191274
Bonalive Orthopedics granules Ref K231528
What Bonalive Biomaterials, Ltd. makes
Bonalive Biomaterials, Ltd. produces bone graft substitutes in granular form, including BonAlive Granules and Bonalive Orthopedics granules, designed for use in orthopedic and dental surgical procedures to support bone regeneration and integration.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Bonalive Biomaterials, Ltd. manufacture?
Bonalive Biomaterials, Ltd. specializes in bone graft substitutes, specifically in granular form. Their products, such as BonAlive Granules and Bonalive Orthopedics granules, are intended for use in orthopedic and dental surgeries to aid bone regeneration and integration.
Where is Bonalive Biomaterials, Ltd. based?
The company is headquartered in the United States. This location is relevant for regulatory oversight and compliance, as their devices are subject to U.S. medical device regulations.
How are Bonalive Biomaterials’ devices classified under FDA regulations?
Bonalive Biomaterials’ devices are classified as Class II medical devices under FDA regulations. This classification is based on their intended use in bone regeneration, which requires moderate levels of regulatory control to ensure safety and effectiveness without the need for the stringent scrutiny of Class III devices.
Which regulatory registries or pathways list Bonalive Biomaterials’ devices?
Bonalive Biomaterials’ devices are listed via the FDA’s 510(k) clearance pathway. This pathway demonstrates that the company’s products are substantially equivalent to legally marketed predicate devices, meeting the FDA’s requirements for Class II clearance.
Information
- Country
- FI