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FDA 510(k)

ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE

K-Number: K110183 · 2011-02-16

ApplicantArthrocare Corp.
Decision Date2011-02-16
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2011-02-16 under 510(k) number K110183. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE?

ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE is a medical device that received FDA 510(k) clearance on 2011-02-16. The listed applicant is Arthrocare Corp.. The 510(k) number is K110183.

When did ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE receive FDA 510(k) clearance?

ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE received FDA 510(k) clearance on 2011-02-16, under 510(k) number K110183.

Who is the listed applicant for ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE?

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

What is the FDA product code for ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE?

The FDA product code for ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE is NDN.

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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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