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HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) Class II

FDA Device Classification

Classification Details

Product Code
HBE
Device Class
Class II
Regulation Number
882.4310
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250815hublyHubly Drill (H100)November 6, 2025
K252060phasor healthGREENOctober 31, 2025
K252662nakanishiUniBurSeptember 19, 2025
K251433surgify medicalSurgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070June 4, 2025
K250380surgify medicalSurgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.0March 13, 2025
K250374stryker instrumentsiBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm PrecisionMarch 11, 2025
K232684surgify medicalSurgify HaloNovember 29, 2023
K230619hublyHubly Electric Drill (H100)May 4, 2023
K223199biomet microfixation2.1 x 255mm Drill, 22mm StopNovember 15, 2022
K213072biomet micofixation2.1 x 255mm Drill, 22mm StopAugust 23, 2022
K213208biomet microfixationTwist DrillsDecember 23, 2021
K213454medtronic powered surgical solutionsMidas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas November 23, 2021
K202120nakanishiP300 AttachmentOctober 22, 2021
K203739aesculapELAN 4 Electro Motor SystemAugust 24, 2021
K210377stryker corporationStryker iBur hubs and cutting accessoriesJune 30, 2021
K191479adeor medicalVelocity Alpha Highspeed Surgical Drill SystemApril 11, 2021
K183203aesculapELAN 4 ToolsAugust 9, 2019
K183545anspach effortAnspach Helix Dissection ToolsJuly 19, 2019
K191049stryker corporationStryker MIS and Footed AttachmentsJune 18, 2019
K190172strykerStryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsJune 14, 2019