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Sign in to claim this brandAmedica Corp.
US
Last updated May 23, 2026
What Amedica Corp. makes
Amedica Corp. manufactures single-use internal spinal fixation procedure kits and sterile bone-screw systems for spinal stabilization. Their portfolio includes vertebral body prostheses designed for spinal fusion procedures, primarily under the Valeo Spacer System and Valeo Fusion System brands.
The company’s devices are classified under FDA categories Class I and Class II, with records maintained in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Amedica Corp. manufacture?
Amedica Corp. specializes in devices for spinal stabilization, including single-use internal spinal fixation procedure kits, sterile bone-screw internal spinal fixation systems, and vertebral body prostheses. Their products are primarily used in spinal fusion procedures and are branded under systems like the Valeo Spacer System and Valeo Fusion System. These devices are designed to support surgical interventions for spinal conditions.
Where is Amedica Corp. based, and what does that mean for its regulatory oversight?
Amedica Corp. is based in the United States, which means its devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration). The FDA classifies their products as either Class I or Class II, depending on the risk level and intended use. This classification determines the regulatory pathway for authorization, such as 510(k) clearance for Class II devices, while Class I devices may require general controls or exemptions.
Which regulatory registries or databases list Amedica Corp.’s devices?
Amedica Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling better tracking, transparency, and regulatory compliance. This database is publicly accessible and helps healthcare providers, regulators, and patients identify and verify the devices in use.
How are Amedica Corp.’s devices classified by the FDA, and why does this matter?
Amedica Corp.’s devices are classified as either Class I or Class II by the FDA. Class I devices generally pose the lowest risk and may only require compliance with general controls, while Class II devices involve moderate risk and require additional premarket submissions, such as a 510(k) clearance, to demonstrate safety and effectiveness. This classification influences the regulatory requirements, labeling, and post-market surveillance needed for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (3022)
Page 53 of 61| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Taurus Pedicle Screw System | X | FDA UDI | Class II | Unknown |
| Valeo Spacer System | C | FDA UDI | Class II | Unknown |
| Valeo Spacer System | A | FDA UDI | Class II | Active |
| Valeo Spacer System | A | FDA UDI | Class II | Unknown |
| Valeo Spacer System | D | FDA UDI | Class II | Active |
| Valeo Spacer System | B | FDA UDI | Class II | Unknown |
| Valeo Spacer System | B | FDA UDI | Class II | Active |
| Valeo Spacer System | D | FDA UDI | Class II | Unknown |
| Valeo Spacer System | C | FDA UDI | Class II | Active |
| Preference 2 | C | FDA UDI | Class II | Unknown |
| Taurus Pedicle Screw System | B | FDA UDI | Class II | Unknown |
| Valeo Spacer System | B | FDA UDI | Class II | Active |
| Taurus Pedicle Screw System | C | FDA UDI | Class II | Unknown |
| Valeo Spacer System | H | FDA UDI | Class II | Unknown |
| Preference 2 | B | FDA UDI | Class II | Unknown |
| Valeo Spacer System | H | FDA UDI | Class II | Active |
| Taurus Pedicle Screw System | B | FDA UDI | Class II | Unknown |
| Taurus Pedicle Screw System | B | FDA UDI | Class II | Unknown |
| Valeo Spacer System | B | FDA UDI | Class II | Unknown |
| Valeo Spacer System | A | FDA UDI | Class II | Unknown |
| Valeo Spacer System | E | FDA UDI | Class II | Unknown |
| Valeo Spacer System | C | FDA UDI | Class II | Active |
| Preference 2 | A | FDA UDI | Class II | Unknown |
| Valeo Spacer System | C | FDA UDI | Class II | Unknown |
| Taurus Pedicle Screw System | B | FDA UDI | Class II | Unknown |
| Valeo Spacer System | B | FDA UDI | Class II | Active |
| Valeo Spacer System | A | FDA UDI | Class II | Active |
| Preference 2 | E | FDA UDI | Class II | Unknown |
| Preference 2 | G | FDA UDI | Class II | Unknown |
| Preference 2 | D | FDA UDI | Class II | Unknown |
| Valeo Spacer System | F | FDA UDI | Class II | Active |
| Taurus Pedicle Screw System | C | FDA UDI | Class II | Unknown |
| Valeo Spacer System | C | FDA UDI | Class II | Active |
| Valeo Spacer System | H | FDA UDI | Class II | Active |
| Valeo Spacer System | A | FDA UDI | Class II | Active |
| Taurus Pedicle Screw System | B | FDA UDI | Class II | Unknown |
| Valeo Spacer System | D | FDA UDI | Class II | Unknown |
| Valeo Spacer System | C | FDA UDI | Class II | Unknown |
| Valeo Spacer System | C | FDA UDI | Class II | Active |
| Preference 2 | T | FDA UDI | Class II | Active |
| Valeo Spacer System | B | FDA UDI | Class II | Unknown |
| Preference 2 | C | FDA UDI | Class II | Unknown |
| Preference 2 | G | FDA UDI | Class II | Unknown |
| Valeo Spacer System | A | FDA UDI | Class II | Active |
| Valeo Spacer System | E | FDA UDI | Class II | Unknown |
| Valeo Spacer System | B | FDA UDI | Class II | Unknown |
| Preference 2 | B | FDA UDI | Class II | Unknown |
| Valeo Spacer System | H | FDA UDI | Class II | Active |
| Valeo Spacer System | A | FDA UDI | Class II | Active |
| Valeo Spacer System | C | FDA UDI | Class II | Unknown |
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