Amber Implants
NL Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
VCFix Spinal System Ref K250637
FDA establishments
- Amber Implants BV The Hague Zuid-Holland · NL FEI 3043534478
What Amber Implants makes
Amber Implants manufactures the VCFix Spinal System, a device designed for spinal stabilization in vertebral compression fractures, providing internal fixation to support vertebral body integrity.
The VCFix Spinal System is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does Amber Implants manufacture?
Amber Implants specializes in spinal stabilization devices. Specifically, the company produces the VCFix Spinal System, which is designed to treat vertebral compression fractures by providing internal fixation to maintain vertebral body integrity. This device focuses on orthopedic applications within spinal care.
Where is Amber Implants based, and does it operate internationally?
Amber Implants is headquartered in the United States. While the company’s primary operations are based there, the availability of its devices internationally depends on regulatory pathways in each country. The VCFix Spinal System is currently authorized for use in markets where applicable regulatory submissions have been completed.
How are the devices manufactured by Amber Implants classified under medical device regulations?
The VCFix Spinal System is classified as a Class II medical device under FDA regulations. This classification typically indicates moderate risk and requires compliance with specific controls, including performance standards and post-market surveillance, to ensure safety and effectiveness. The classification helps determine the regulatory pathway for authorization.
Which regulatory registries list devices manufactured by Amber Implants?
The VCFix Spinal System is listed in the FDA’s 510(k) clearance registry, which documents devices that have undergone the 510(k) premarket notification process. This registry serves as a public reference for authorized devices in the U.S., demonstrating compliance with FDA requirements before market introduction.
Information
- Country
- NL