Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231

Q: What is the product code of K073336?

The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.

FDA 510(k) K073336 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK073336

Submission

Device name: Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231
Applicant: Codman & Shurtleff, Inc.
Raynham, MA, US
Received: November 28, 2007
Decision date: January 4, 2008
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4305
Specialty: Neurology

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K231403	evoDrill Cranial PerforatorHBF · Traditional	Evonos GmbH & Co. KG	03/06/2024SE
K213228	NeuroLine Disposable Cranial Perforator with Hudson endHBF · Traditional	Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.	06/20/2022SE
K183581	Codman Disposable PerforatorsHBF · Special	Integra Lifesciences Corp.	01/20/2019SE
K141455	Easydrill Autostop Cranial PerforatorHBF · Traditional	Micromar Ind. Com. , Ltd.	03/16/2015SE
K121253	Meridian Cranial PerforatorHBF · Traditional	Adeor Medical Technologies GmbH	07/17/2012SE
K082010	Stryker Disposable Cranial Perforator BitHBF · Traditional	Stryker Ireland Ltd., Instruments Division	12/29/2008SE
K082637	Cranial PerforatorHBF · Traditional	The Anspach Effort, Inc.	12/22/2008SE
K071931	Codman Disposable Perforator, Model(S) 26-1222, 26-1223HBF · Traditional	Codman & Shurtleff, Inc.	10/22/2007SE
K032970	Acra-Cut Xpress 120HBF · Traditional	Acra Cut, Inc.	12/08/2003SE

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Questions and answers

When was Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231 cleared by the FDA?

Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231 (K073336) received a 510(k) decision of Substantially Equivalent on January 4, 2008, 37 days after the submission was received.

What is the product code of K073336?

The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.