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Sign in to claim this brandBIOFUSION MANAGEMENT AND MANUFACTURING, LLC
US
Last updated May 23, 2026
What BIOFUSION MANAGEMENT AND MANUFACTURING, LLC makes
The company produces sacroiliac joint implants for transarticular fixation and arthrodesis, along with reusable orthopaedic positioning instruments for prosthesis implantation. It also manufactures endoscopic dilators for soft-tissue release, reusable surgical tools such as bone taps, cannulated drill bits, and depth gauges, as well as bone graft funnels and general surgical procedure kits.
These devices are regulated under the FDA’s classification system as Class I and Class II, with most entries listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
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 Biofusion Management and Manufacturing, LLC primarily manufacture?
Biofusion Management and Manufacturing, LLC specializes in orthopaedic and surgical devices. Their portfolio includes sacroiliac joint implants designed for transarticular fixation and arthrodesis, reusable orthopaedic instruments for prosthesis positioning, and endoscopic dilators for soft-tissue release. They also produce reusable tools like bone taps, cannulated surgical drill bits, surgical depth gauges, bone graft funnels, and general surgical procedure kits. These devices are tailored for orthopaedic and minimally invasive surgical applications.
Where is Biofusion Management and Manufacturing, LLC based, and how does this affect its regulatory compliance?
Biofusion Management and Manufacturing, LLC is based in the United States. As a U.S.-based manufacturer, the company must comply with the regulatory requirements set by the FDA, including device classification, UDI registration, and adherence to quality system regulations. The FDA’s jurisdiction ensures that their devices meet safety, effectiveness, and performance standards applicable in the U.S. market.
Which regulatory registries or databases list the devices manufactured by Biofusion Management and Manufacturing, LLC?
The devices produced by Biofusion Management and Manufacturing, LLC are primarily listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in regulatory oversight. This listing is critical for compliance and market distribution in the U.S.
How are the devices manufactured by Biofusion Management and Manufacturing, LLC classified under FDA regulations?
The devices from Biofusion Management and Manufacturing, LLC fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification determines the regulatory pathway and oversight required for each device type, ensuring appropriate scrutiny based on potential patient risk.
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
- 125905168
Catalogue (63)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Si-Restore | 1701-111040 | FDA UDI | Class II | Active |
| Si-Restore | 2001-109555 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300019 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300055 | FDA UDI | Class I | Active |
| Si-Restore | 2001-111060 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300025 | FDA UDI | Class I | Active |
| Si-Restore | 2001-109565 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300027 | FDA UDI | Class I | Active |
| Si-Restore | 2001-109540 | FDA UDI | Class II | Active |
| Si-Restore | 1701-111065 | FDA UDI | Class II | Active |
| Si-Restore | 1701-109535 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300039 | FDA UDI | Class I | Active |
| Si-Restore | 2001-111055 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300001 | FDA UDI | Class I | Active |
| Si-Restore | 2001-111065 | FDA UDI | Class II | Active |
| Si-Restore | 2001-109560 | FDA UDI | Class II | Active |
| Si-Restore | 1701-109560 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300047 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300063 | FDA UDI | Class I | Active |
| Si-Restore | 1701-111045 | FDA UDI | Class II | Active |
| Si-Restore | 2001-111035 | FDA UDI | Class II | Active |
| Si-Restore | 2001-111040 | FDA UDI | Class II | Active |
| Si-Restore | 2001-111045 | FDA UDI | Class II | Active |
| Si-Restore | 1701-111060 | FDA UDI | Class II | Active |
| Si-Restore | 1701-500011 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300017 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300049 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300045 | FDA UDI | Class I | Active |
| Si-Restore | 1701-301095 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300031 | FDA UDI | Class I | Active |
| Si-Restore | 1701-109545 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300095 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300053 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300003 | FDA UDI | Class I | Active |
| Si-Restore | 1701-109555 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300110 | FDA UDI | Class I | Active |
| Si-Restore | 1701-109550 | FDA UDI | Class II | Active |
| Si-Restore | 1701-109565 | FDA UDI | Class II | Active |
| Si-Restore | 1701-111050 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300057 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300007 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300029 | FDA UDI | Class I | Active |
| Si-Restore | 1701-300043 | FDA UDI | Class I | Active |
| Si-Restore | 2001-109550 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300015 | FDA UDI | Class I | Active |
| Si-Restore | 1701-301110 | FDA UDI | Class I | Active |
| Si-Restore | 1701-111055 | FDA UDI | Class II | Active |
| Si-Restore | 1701-109540 | FDA UDI | Class II | Active |
| Si-Restore | 1701-111035 | FDA UDI | Class II | Active |
| Si-Restore | 1701-300023 | FDA UDI | Class I | Active |
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