Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2017-11-29 under approval 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. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K172019.

When was Brisbane ALIF Device, Gladstone ALIF Device approved by the FDA?

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

What company makes Brisbane ALIF Device, Gladstone ALIF Device?

Brisbane ALIF Device, Gladstone ALIF Device is manufactured by Signature Orthopaedics Pty, Ltd..

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.

Other Devices by Signature Orthopaedics Pty, Ltd.

K160159Active-X Total Knee System K161155Origin Coxa Vara Hip Stem K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner K172020Arlington PLIF/TLIF Cage K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System K170613Genius Total Knee System

View all 42 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc.

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.

↑