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FDA 510(k)

ACU-CUT VERTEBRAL AUGMENTATION SYSTEM

K-Number: K113452 · 2012-02-17

ApplicantAscendx Spine, Inc.
Decision Date2012-02-17
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACU-CUT VERTEBRAL AUGMENTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ascendx Spine, Inc.. It received FDA 510(k) clearance on 2012-02-17 under 510(k) number K113452. 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 ACU-CUT VERTEBRAL AUGMENTATION SYSTEM?

ACU-CUT VERTEBRAL AUGMENTATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Ascendx Spine, Inc.. The 510(k) number is K113452.

When did ACU-CUT VERTEBRAL AUGMENTATION SYSTEM receive FDA 510(k) clearance?

ACU-CUT VERTEBRAL AUGMENTATION SYSTEM received FDA 510(k) clearance on 2012-02-17, under 510(k) number K113452.

Who is the listed applicant for ACU-CUT VERTEBRAL AUGMENTATION SYSTEM?

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

What is the FDA product code for ACU-CUT VERTEBRAL AUGMENTATION SYSTEM?

The FDA product code for ACU-CUT VERTEBRAL AUGMENTATION SYSTEM is NDN.

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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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