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FDA 510(k)

GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K110990 · 2011-07-25

ApplicantGold Standard Orthopedics, LLC
Decision Date2011-07-25
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gold Standard Orthopedics, LLC. It received FDA 510(k) clearance on 2011-07-25 under 510(k) number K110990. 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 GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM?

GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-25. The listed applicant is Gold Standard Orthopedics, LLC. The 510(k) number is K110990.

When did GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2011-07-25, under 510(k) number K110990.

Who is the listed applicant for GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM?

The FDA 510(k) record lists Gold Standard Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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 Gold Standard Orthopedics, LLC 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.

K071274GSO GS1 SPACER

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

View on FDA Database →

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

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