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FDA 510(k)

PREMIER ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K992110 · 1999-09-14

ApplicantSofamor Danek USA
Decision Date1999-09-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PREMIER ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA. It received FDA 510(k) clearance on 1999-09-14 under 510(k) number K992110. 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 PREMIER ANTERIOR CERVICAL PLATE SYSTEM?

PREMIER ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-14. The listed applicant is Sofamor Danek USA. The 510(k) number is K992110.

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

PREMIER ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 1999-09-14, under 510(k) number K992110.

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

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

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

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

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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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