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FDA 510(k)

OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

K-Number: K042073 · 2005-02-07

ApplicantOlsen Medical
Decision Date2005-02-07
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Medical. It received FDA 510(k) clearance on 2005-02-07 under 510(k) number K042073. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM?

OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-02-07. The listed applicant is Olsen Medical. The 510(k) number is K042073.

When did OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM receive FDA 510(k) clearance?

OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM received FDA 510(k) clearance on 2005-02-07, under 510(k) number K042073.

Who is the listed applicant for OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM?

The FDA 510(k) record lists Olsen Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM?

The FDA product code for OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM is KWQ.

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Other records listing Olsen Medical 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.

K130669SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPSK111262ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOPK080187OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPSK072937OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET

Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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