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FDA 510(k)

CYCLONE ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K031214 · 2003-09-23

ApplicantEncore Medical L.P.
Decision Date2003-09-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CYCLONE ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2003-09-23 under 510(k) number K031214. 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 CYCLONE ANTERIOR CERVICAL PLATE SYSTEM?

CYCLONE ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Encore Medical L.P.. The 510(k) number is K031214.

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

CYCLONE ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2003-09-23, under 510(k) number K031214.

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

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

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

The FDA product code for CYCLONE ANTERIOR CERVICAL PLATE SYSTEM is 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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