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Sign in to claim this brandAbsolute Advantage Medical, LLC
US
Last updated May 23, 2026
What Absolute Advantage Medical, LLC makes
Absolute Advantage Medical, LLC manufactures spinal fixation devices, including non-bioabsorbable bone screws, polymeric interbody fusion cages, and spinal fixation plates. Their portfolio also includes reusable surgical tools such as drill guides, instrument trays, fluted drill bits, and orthopaedic implant impactors, as well as spinal implant trial systems for preoperative planning. The company produces devices specifically for cervical spine procedures under the Accufuse Cervical System brand.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) and Unique Device Identification (UDI) systems. These devices are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device standards. The manufacturer operates from 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 Absolute Advantage Medical, LLC primarily manufacture?
Absolute Advantage Medical, LLC specializes in spinal fixation devices, including non-bioabsorbable bone screws, polymeric interbody fusion cages, and spinal fixation plates. Their product line also covers reusable surgical tools like drill guides, instrument trays, fluted drill bits, and orthopaedic implant impactors. Additionally, they offer spinal implant trial systems for preoperative planning, with a focus on cervical spine procedures under the Accufuse Cervical System brand.
Where is Absolute Advantage Medical, LLC based, and what does that mean for its regulatory compliance?
Absolute Advantage Medical, LLC is based in the United States, which means its devices are subject to U.S. regulatory requirements. Since their products are classified as Class II medical devices, they must comply with FDA regulations, including authorisation through the 510(k) pathway and adherence to Unique Device Identification (UDI) standards. This ensures their devices meet U.S. safety and performance criteria.
Which regulatory registries or databases list Absolute Advantage Medical, LLC’s devices?
Absolute Advantage Medical, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identification (UDI) system. These registries confirm that their products have undergone the necessary authorisation processes to comply with U.S. medical device regulations, ensuring transparency and traceability.
How are Absolute Advantage Medical, LLC’s devices classified under FDA regulations?
Absolute Advantage Medical, LLC’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. Class II devices must go through the 510(k) process to demonstrate substantial equivalence to a legally marketed predicate device.
What does it mean for Absolute Advantage Medical, LLC’s devices to be authorised through the 510(k) and UDI systems?
The 510(k) process is a premarket submission that demonstrates a new device is substantially equivalent to an existing, legally marketed device (the predicate). Once authorised, it confirms the device meets FDA safety and performance requirements. The Unique Device Identification (UDI) system assigns a unique product code to each device, enabling better tracking, traceability, and risk management throughout the device’s lifecycle. Together, these systems ensure compliance with U.S. regulatory standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 056248579
Catalogue (144)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Accufuse Cervical System | C141205 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-10 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-20-04 | FDA UDI | Class II | Active |
| Accufuse Cervical System | FS4520 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C161409 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-12-10 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 2P32 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 2P23 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 2P26 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 1P12C10 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 1P10C8 | FDA UDI | Class II | Active |
| Accufuse Cervical System | VB4018 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C161405 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C161410 | FDA UDI | Class II | Active |
| Accufuse Cervical System | FB4518 | FDA UDI | Class II | Active |
| Accufuse Cervical System | FB4020 | FDA UDI | Class II | Active |
| Accufuse Cervical System | FS4020 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C141210 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-20-05 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-12-12 | FDA UDI | Class II | Active |
| Accufuse Cervical System | FS4016 | FDA UDI | Class II | Active |
| Accufuse Cervical System | VS4014 | FDA UDI | Class II | Active |
| Accufuse Cervical System | VS4514 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C161412 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-20-03 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-12-06 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-11-10 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-17-08 | FDA UDI | Class II | Active |
| Accufuse Cervical System | FS4514 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 1P11C9 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C121209 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-04 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-12-08 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C121206 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-03-16 | FDA UDI | Class II | Active |
| Accufuse Cervical System | VB4020 | FDA UDI | Class II | Active |
| Accufuse Cervical System | FS4512 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C181509 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 10-20-01 | FDA UDI | Class II | Active |
| Accufuse Cervical System | VS4516 | FDA UDI | Class II | Active |
| Accufuse Cervical System | 2P29 | FDA UDI | Class II | Active |
| Accufuse Cervical System | C141211 | FDA UDI | Class II | Active |
| Accufuse Cervical System | FB4512 | FDA UDI | Class II | Active |
| ACCUFUSE Cervical System | K181471 | FDA 510(k) | Class II | Active |
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