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FDA 510(k)

Brisbane ALIF Device, Gladstone ALIF Device

K-Number: K172019 · 2017-11-29

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2017-11-29
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Brisbane ALIF Device, Gladstone ALIF Device is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172019. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brisbane ALIF Device, Gladstone ALIF Device?

Brisbane ALIF Device, Gladstone ALIF Device is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K172019.

When did Brisbane ALIF Device, Gladstone ALIF Device receive FDA 510(k) clearance?

Brisbane ALIF Device, Gladstone ALIF Device received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172019.

Who is the listed applicant for Brisbane ALIF Device, Gladstone ALIF Device?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brisbane ALIF Device, Gladstone ALIF Device?

The FDA product code for Brisbane ALIF Device, Gladstone ALIF Device is OVD.

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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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