Surgify Halo

FDA 510(k) K232684 · Surgify Medical OY

Substantially Equivalent

510(k) numberK232684

Submission

Device name
Surgify Halo
Applicant
Surgify Medical OY
Espoo, FI
Received
September 1, 2023
Decision date
November 29, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4310
Specialty
Neurology

Other 510(k)s with product code HBE

510(k)DeviceApplicantDecision
K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…HBE · Traditional Surgify Medical OY03/26/2026SE
K250815Hubly Drill (H100)HBE · Traditional Hubly, Inc.11/06/2025SE
K252060GreenHBE · Traditional Phasor Health, LLC10/31/2025SE
K252662UniBurHBE · Traditional Nakanishi, Inc.09/19/2025SE
K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special Surgify Medical OY06/04/2025SE
K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special Surgify Medical OY03/13/2025SE
K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special Stryker Instruments03/11/2025SE
K230619Hubly Electric Drill (H100)HBE · Traditional Hubly, Inc.05/04/2023SE
K2231992.1 x 255mm Drill, 22mm StopHBE · Special Biomet Microfixation11/15/2022SE
K2130722.1 x 255mm Drill, 22mm StopHBE · Traditional Biomet Micofixation08/23/2022SE

More from Biomet Micofixation

510(k)DeviceDecision
K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…HBE · Traditional 03/26/2026SE
K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special 06/04/2025SE
K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special 03/13/2025SE

Questions and answers

When was Surgify Halo cleared by the FDA?

Surgify Halo (K232684) received a 510(k) decision of Substantially Equivalent on November 29, 2023, 89 days after the submission was received.

What is the product code of K232684?

The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.