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FDA 510(k)

BLUE MOUNTAIN CERVICAL PLATE

K-Number: K112809 · 2012-06-20

ApplicantQualgenix, LLC
Decision Date2012-06-20
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLUE MOUNTAIN CERVICAL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Qualgenix, LLC. It received FDA 510(k) clearance on 2012-06-20 under 510(k) number K112809. 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 BLUE MOUNTAIN CERVICAL PLATE?

BLUE MOUNTAIN CERVICAL PLATE is a medical device that received FDA 510(k) clearance on 2012-06-20. The listed applicant is Qualgenix, LLC. The 510(k) number is K112809.

When did BLUE MOUNTAIN CERVICAL PLATE receive FDA 510(k) clearance?

BLUE MOUNTAIN CERVICAL PLATE received FDA 510(k) clearance on 2012-06-20, under 510(k) number K112809.

Who is the listed applicant for BLUE MOUNTAIN CERVICAL PLATE?

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

What is the FDA product code for BLUE MOUNTAIN CERVICAL PLATE?

The FDA product code for BLUE MOUNTAIN CERVICAL PLATE is KWQ.

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Other records listing Qualgenix, 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.

K112696TWIN PEAKS LUMBAR CAGE

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.

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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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