Fixit Headrest Clamp System

Q: What is the product code of K083803?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.

FDA 510(k) K083803 · Medicon EG

Substantially Equivalent

510(k) numberK083803

Submission

Device name: Fixit Headrest Clamp System
Applicant: Medicon EG
Tuttlingen, DE
Received: December 22, 2008
Decision date: March 10, 2010
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4460
Specialty: Neurology

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K193438	DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…HBL · Traditional	Pro Med Instruments GmbH	06/02/2020SE
K191740	DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional	Pro Med Instruments GmbH	02/21/2020SE
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K191979	DORO QR3 XTom Headholder SystemHBL · Traditional	Pro Med Instruments GmbH	10/22/2019SE
K163322	TZ SKULL PIN AdultHBL · Traditional	Tz Medical, Inc.	02/23/2017SE
K142238	MAYFIELD Skull ClampHBL · Traditional	Integra LifeSciences Corporation	11/24/2014SE

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Questions and answers

When was Fixit Headrest Clamp System cleared by the FDA?

Fixit Headrest Clamp System (K083803) received a 510(k) decision of Substantially Equivalent on March 10, 2010, 443 days after the submission was received.

What is the product code of K083803?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.