Medilink
Country not established
- Devices
- 1
What Medilink makes
Medilink manufactures orthopedic implants under the OSTEOSPACE brand, designed for spinal and skeletal fixation. These devices include internal fixation systems for stabilizing fractures, spinal fusion cages, and structural bone void fillers used in reconstructive surgeries. The portfolio focuses on products intended for long-term structural support in orthopedic and spinal procedures.
The company’s devices fall under FDA Class II regulatory classification, requiring Premarket Approval (PMA) authorization. OSTEOSPACE products are listed in the FDA’s PMA registry. Medilink operates as a US-based manufacturer, adhering to domestic regulatory requirements for medical devices.
Catalogue
Osteospace Ref P010058
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Medilink have in the registry?
The registry currently lists 1 device for Medilink. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medilink's devices?
Among its 1 most recently registered device, Medilink has devices listed in FDA PMA (1 device).
What risk classes do Medilink's devices fall under?
Among its 1 most recently registered device, the classes recorded for Medilink's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medilink in the registry?
The most recently registered devices listed for Medilink include OSTEOSPACE.