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510(k) Data Aggregation
Manufacturer
Date Cleared
2026-03-26
(127 days)
Product Code
Regulation Number
882.4310Type
TraditionalPanel
NeurologyAge Range
All
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures.
Device Description
The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems.
The Surgify Halo comprises:
- A head part, which is shaped to have cutting edge(s) to cut hard tissue.
- Dynamically positioned ring surrounding the burr head that controls the exposure of the cutting edge(s) decreasing chattering and enabling the tissue selective feature.
- A shaft, which transfers rotary movement from the drill motor to the head.
- An end-attachment feature, which allows the Surgify Halo to be locked to commonly marketed high-speed, surgical drill systems.
AI/ML Overview
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