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FDA 510(k)

STRYKER DISPOSABLE CRANIAL PERFORATOR BIT

K-Number: K082010 · 2008-12-29

ApplicantStryker Ireland Ltd., Instruments Division
Decision Date2008-12-29
Product CodeHBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER DISPOSABLE CRANIAL PERFORATOR BIT is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Ireland Ltd., Instruments Division. It received FDA 510(k) clearance on 2008-12-29 under 510(k) number K082010. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER DISPOSABLE CRANIAL PERFORATOR BIT?

STRYKER DISPOSABLE CRANIAL PERFORATOR BIT is a medical device that received FDA 510(k) clearance on 2008-12-29. The listed applicant is Stryker Ireland Ltd., Instruments Division. The 510(k) number is K082010.

When did STRYKER DISPOSABLE CRANIAL PERFORATOR BIT receive FDA 510(k) clearance?

STRYKER DISPOSABLE CRANIAL PERFORATOR BIT received FDA 510(k) clearance on 2008-12-29, under 510(k) number K082010.

Who is the listed applicant for STRYKER DISPOSABLE CRANIAL PERFORATOR BIT?

The FDA 510(k) record lists Stryker Ireland Ltd., Instruments Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER DISPOSABLE CRANIAL PERFORATOR BIT?

The FDA product code for STRYKER DISPOSABLE CRANIAL PERFORATOR BIT is HBF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Stryker Ireland Ltd., Instruments Division as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073633STRYKER ESSX MICRODEBRIDER SYSTEM

Related Devices (Code: HBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254177Disposable Sterile Skull Drill (LZ)Guizhou Zirui Technology Co., Ltd.K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KGK213228NeuroLine Disposable Cranial Perforator with Hudson endEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.K183581Codman Disposable PerforatorsIntegra Lifesciences Corp.K121253MERIDIAN CRANIAL PERFORATORAdeor Medical Technologies GmbHK082637CRANIAL PERFORATORThe Anspach Effort, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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