iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC);

Q: What is the product code of K250374?

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

FDA 510(k) K250374 · Stryker Instruments

Substantially Equivalent

510(k) numberK250374

Submission

Device name: iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC);
Applicant: Stryker Instruments
Portage, MI, US
Received: February 10, 2025
Decision date: March 11, 2025
Decision: Substantially Equivalent (SESE)
Type: Special 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)	Device	Applicant	Decision
K253627	Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…HBE · Traditional	Surgify Medical OY	03/26/2026SE
K250815	Hubly Drill (H100)HBE · Traditional	Hubly, Inc.	11/06/2025SE
K252060	GreenHBE · Traditional	Phasor Health, LLC	10/31/2025SE
K252662	UniBurHBE · Traditional	Nakanishi, Inc.	09/19/2025SE
K251433	Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special	Surgify Medical OY	06/04/2025SE
K250380	Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special	Surgify Medical OY	03/13/2025SE
K232684	Surgify HaloHBE · Traditional	Surgify Medical OY	11/29/2023SE
K230619	Hubly Electric Drill (H100)HBE · Traditional	Hubly, Inc.	05/04/2023SE
K223199	2.1 x 255mm Drill, 22mm StopHBE · Special	Biomet Microfixation	11/15/2022SE
K213072	2.1 x 255mm Drill, 22mm StopHBE · Traditional	Biomet Micofixation	08/23/2022SE

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510(k)	Device	Decision
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K253679	Hydro Irrigation SystemGWG · Traditional	05/08/2026SE
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K250327	OptaBlate Radiofrequency (RF) Generator SystemGEI · Special	04/15/2025SE
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Questions and answers

When was iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); cleared by the FDA?

iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); (K250374) received a 510(k) decision of Substantially Equivalent on March 11, 2025, 29 days after the submission was received.

What is the product code of K250374?

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