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FDA 510(k)

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K103491 · 2011-02-14

ApplicantA Johnson & Johnson Company
Decision Date2011-02-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is A Johnson & Johnson Company. It received FDA 510(k) clearance on 2011-02-14 under 510(k) number K103491. 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 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM?

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-14. The listed applicant is A Johnson & Johnson Company. The 510(k) number is K103491.

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

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2011-02-14, under 510(k) number K103491.

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

The FDA 510(k) record lists A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

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

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

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Official Source

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

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