Surgify Halo (54.085.SHD.H1) +4 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250380 FDA 510(k)
- FDA Product Code
- HBE FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4310 FDA 510(k)
- Regulation Number
- 882.4310 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Surgify Halo is a powered surgical burr classified as a drill, burr, trephine, or accessory (simple, powered), designed for shaping and removing hard tissue and bone. It features a rotary shank for motion transfer, locking mechanisms for secure drill attachment, and a burr head with cutting edges optimized for precision surgical applications. This device is intended for use in neurosurgical, spinal, ENT, and general surgical procedures where controlled bone resection is required.
The Surgify Halo is supplied as a sterile, single-use device for hospital settings and is compatible with high-speed surgical drill systems. It adheres to regulatory standards under the Medical Device Regulation (MDR) and has received FDA 510(k) clearance as substantially equivalent, with a classification under regulation number 882.4310. Each variant is identified by its unique reference code and size, ensuring proper selection for specific surgical needs. Storage and handling follow standard sterile instrument protocols.
Frequently asked questions
What types of surgical procedures is the Surgify Halo designed for, and how does its design support those uses?
The Surgify Halo is specifically designed for neurosurgical, spinal, ENT (ear, nose, and throat), and general surgical procedures where controlled bone resection is required. Its rotary shank enables precise motion transfer to the burr head, while the locking mechanisms ensure secure attachment to high-speed surgical drills. The cutting edges of the burr head are optimized for accuracy, making it suitable for delicate and precise bone shaping in these specialized fields.
Is the Surgify Halo intended for single-use or reusable applications, and what does this mean for hospital workflows?
The Surgify Halo is supplied as a sterile, single-use device, which means it is intended for one-time use per patient and must be discarded after use. This design choice simplifies hospital workflows by eliminating the need for sterilization between procedures, reducing infection risks, and ensuring consistent performance without wear or contamination concerns.
How do I determine the correct size or variant of the Surgify Halo for my surgical needs, and what are the available options?
The Surgify Halo comes in five distinct variants, each identified by a unique reference code (e.g., 54.085.SHD.H1, 54.140.SHD.H1, etc.), which correspond to different sizes and applications. The codes help ensure proper selection based on the specific surgical requirements—such as bone density, procedure type, or anatomical location. Referencing the manufacturer’s documentation or consulting with a surgical specialist can help match the correct variant to your procedure.
How should the Surgify Halo be stored, and what precautions should be taken to maintain its sterility?
The Surgify Halo must be stored according to standard sterile instrument protocols to preserve its sterility. Since it is single-use, it should remain in its original, sealed packaging until immediately before use. Storage should be in a clean, dry environment away from direct sunlight or extreme temperatures, following the manufacturer’s guidelines to prevent contamination or degradation of the device’s integrity.
What regulatory pathways has the Surgify Halo followed, and what does this mean for its use in clinical settings?
The Surgify Halo has undergone FDA 510(k) clearance and adheres to the Medical Device Regulation (MDR) standards. This means it has been evaluated for safety and effectiveness by regulatory authorities and is classified under FDA regulation number 882.4310 as a Class II device. Clinicians can rely on its compliance with these pathways, ensuring it meets established standards for powered surgical drills and accessories in neurosurgical, spinal, ENT, and general surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify ..., Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify ..., Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250380 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgify Medical Oy
Sources (2)
- FDA 510(k) K250380 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026