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FDA 510(k)

ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K121514 · 2012-12-14

ApplicantCorelink, LLC
Decision Date2012-12-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANODYNE ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K121514. 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 ANODYNE ANTERIOR CERVICAL PLATE SYSTEM?

ANODYNE ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Corelink, LLC. The 510(k) number is K121514.

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

ANODYNE ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2012-12-14, under 510(k) number K121514.

Who is the listed applicant for ANODYNE ANTERIOR CERVICAL PLATE SYSTEM?

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

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

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

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Other records listing Corelink, LLC as applicant

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Related Devices (Code: KWQ)

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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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